| Job Title | Location |
|---|---|
| Senior Scientist, Antibody & Cytokine Engineering
This is an exciting opportunity to work within an ultra-innovative drug and target discovery company striving to expand the therapeutic potential of proteins and enable the development of better medicines. This position is responsible for developing antibody and cytokine expression and engineering capabilities. The ideal candidate should have theoretical, technical, and hands-on expertise in antibody and cytokine expression and engineering. You will also be responsible for: * Leading antibody and cytokine engineering efforts using state-of-the-art technologies for library construction. * Designing and executing overall antibody and cytokine expression and engineering strategies. * Establishing processes for random and semi-random/rational mutagenesis library design and construction. * Performing antibody and cytokine library screening and selection to isolate optimized variants with drug-like properties. * Performing complex experiments with strong attention to quality, detail, and documentation. * Interpreting data, troubleshooting experiments, and presenting work at both internal and external meetings. * Proactively interacting and effectively collaborating with team members from cross-functions. Desired Skills: * PhD in molecular biology, biochemistry, or a related discipline. * 3-5+ years of experience with antibody and cytokine expression and engineering. * Ability to deliver on antibody and cytokine expression and engineering programs under tight timelines. * Strong in-depth knowledge of antibody and cytokine biology as well as hands-on experience in antibody and cytokine library design, construction, selection, and screening. * Extensive, hands-on experience using modern cloning techniques for DNA construction (e.g., Gibson Assembly, Golden Gate Cloning, etc.) * Experience utilizing structural modeling and sequence analysis software for antibody and cytokine optimization to confer drug-like attributes. * Strong understanding of antibody and cytokine folding and the role of molecular chaperones. * Proven track record of strong problem-solving and troubleshooting skills. * Passion for building a collaborative, multidisciplinary, and determined company culture to make a transformative impact in the industry. * Experience using NGS technologies to address biological questions. * Experience with high-throughput workflows, laboratory automation, and complex data sets. * thirty About the Company: This is a unique and exciting opportunity with a drug and target discovery company that uses innovative synthetic biology and deep learning to expand the therapeutic potential of proteins. |
Lake Oswego, OR |
| Hamilton STAR, Laboratory Automation, Support Engineer
This is an exciting opportunity to work within an ultra-innovative drug and target discovery company striving to expand the therapeutic potential of proteins and enable the development of better medicines. This position is responsible for serving as a Hamilton STAR automation systems expert by assisting lab users, troubleshooting and diagnosing issues, performing minor repairs, and performing preventative maintenance for lab automation systems. You will also be responsible for: * Serving as a Hamilton liquid handling SME for Hamilton STAR, STARlet and STARplus systems as well as other lab automation and liquid handling systems. * Working collaboratively with Automation application engineers and lab users to return liquid handlers to operational status in a timely manner, and to maximize equipment uptime. * Conducting routine equipment performance evaluations and troubleshoot out of specification liquid handlers. * Conducting and improving preventative maintenance plans for the liquid handling fleet. * Providing timely updates and communication to lab users for the status of open tickets. * Adhering to established best practices and providing thoughtful feedback for improvements or changes. * Demonstrating a proactive and enthusiastic approach toward working in a team-oriented environment. Desired Skills: * 3+ years of experience servicing Hamilton STAR, STARlet and STARplus liquid handling systems. * Experience as a lab technician/research associate in a biotech or pharma-based lab a plus. * Hamilton Service or Training Certifications desired. * At least 3 years of applied development experience translating scientific protocols from the lab bench to Hamilton automated systems including requirements gathering and process documentation. * Familiar with peripheral equipment (e.g., plate readers, centrifuges, dispensers). * Experience managing vendor interactions with a focus on hardware installation and qualifications, repairs, and parts supply. * Hands-on experience supporting other types of liquid handlers (Tecan Fluent, Formalatrix Tempest, Labcyte Echo, etc.). * thirty About the Company: This is a unique and exciting opportunity with a drug and target discovery company that uses innovative synthetic biology and deep learning to expand the therapeutic potential of proteins. |
Portland, OR |
| Laboratory Automation, Senior Engineer
This is an exciting opportunity with drug and target discovery company that is striving to expand the therapeutic potential of proteins and enable the development of better medicines. We are seeking a Senior Engineer to join to our innovative and creative team. This position will be responsible for assisting lab users recover from errors, troubleshooting and diagnosing issues, performing minor repairs, and performing preventative maintenance. You will also be responsible for: * Gathering requirements, project scoping, proof of concept designing, and working with end users for refinement and validation testing. * Developing application protocols with a focus on Hamilton instruments and providing support for instrumentation * Serving as the subject matter expert for various pieces of automated equipment promoting best practices for operation, programming, and new application deployment * Optimizing liquid handling performance and perform troubleshooting of application, protocols, and equipment * Contributing to operational excellence initiatives through training content creation and presentation to laboratory staff * Contributing to internal preventative maintenance initiatives, vendor support communications and maintenance scheduling * Contributing to company knowledge base using provided software and tools (e.g. project documentation, contribution to SOP generation, instrument demos and evaluations). Desired Skills: * B.S. or M.S. in a biological/life science. 6-10+ years of experience in laboratory automation in biotech industry. * At least 3 years of applied development experience translating scientific protocols from the lab bench to Hamilton automated systems including requirements gathering and process documentation. * Familiar with peripheral equipment (e.g. plate readers, centrifuges, dispensers). * Experience with coding, specifically in tool specific applications (e.g. C# and Python). * Critical thinking, troubleshooting, and attention to detail. * Ability to work a flexible schedule, including nights and weekends. * Hands-on experience programming Labcyte Echos or Tecan Fluents. * Experience working with Sartorius AMBRs. * Experience combining hardware from different manufactures into integrated platforms or expanding base platforms with vendor specific add-ons. About the Company: This is a unique and exciting opportunity with a drug and target discovery company that uses innovative synthetic biology and deep learning to expand the therapeutic potential of proteins. |
Portland, OR |
| Downstream Process Development Scientist - Microbial
This is a exciting opportunity with a new and growing drug and target discovery company. Harnessing deep learning and synthetic biology to expand therapeutic potential of proteins. This position would focus on downstream process development of therapeutic proteins expressed using a proprietary E. coli expression platform. In this role you will:
Desired Skills:
About the Company: This is a unique and exciting opportunity with a drug and target discovery company that uses innovative synthetic biology and deep learning to expand the therapeutic potential of proteins. |
Portland, OR |
| Bioassay Development, Associate Scientist/Scientist
This is a exciting opportunity with a new and growing drug and target discovery company. Harnessing deep learning and synthetic biology to expand therapeutic potential of proteins. This position would focus on analytical method development and characterization of therapeutic proteins expressed using a proprietary E. coli expression platform. In this role you will:
*THIRTY Desired Skills:
About the Company: This is a unique and exciting opportunity with a drug and target discovery company that uses innovative synthetic biology and deep learning to expand the therapeutic potential of proteins. |
Portland, OR |
| Sr. Scientist, Analytical Development Separations
This is an exciting opportunity with drug and target discovery company that is striving to expand the therapeutic potential of proteins and enable the development of better medicines. We are seeking a self-motivated, passionate, and accomplished Scientist to join our Analytical Development team. The qualified individual will play a significant role in analytical method development and characterization of therapeutic proteins. The candidate will also be responsible for the following: * Exploring new and innovative technologies. * Overseeing routine instrument operation and maintenance. * Training and mentoring junior personnel and personnel from other teams. * Collaborating multidisciplinary with other teams, including Strain Construction, High-Throughput Screening, Fermentation, Purification, and Data Sciences. * Developing and executing laboratory tasks to support the development, optimization, and sample analysis of complex biologics by various chromatographic and electrophoretic separations techniques such as LC (e.g. LC-UV, SEC, IEX, etc.) and CE-SDS, including associated sample preparation techniques (e.g. desalting, sample concentration, protein denaturation or oxidation, etc.). * Operating, maintaining, and installing chromatography instrumentation (e.g. HPLC, CE, etc.). * Writing and reviewing formal reports, including method SOPs, reports, and other technical documents. * Evaluating data trends indicative of product performance, method performance, and/or analyst performance and present internally to team members and senior management. * Leading, mentoring, and inspiring junior team members. * Supporting internal technical teams, including R&D, fermentation, and purification process development teams. * Maintaining accurate documentation of all work in laboratory notebooks. Desired Skills: * PhD in Analytical Chemistry, Biochemistry, or related scientific discipline degree with 0-2 years of industry or post-doc experience, or Master's with equivalent experience. * Proven experience in method development, testing, qualifications and validations. * Comprehensive hands-on knowledge of protein analytics and characterization, including LC (e.g. LC-UV, SEC, IEX, etc.) and CE-SDS OR knowledge of immunoassay methods for quantification, impurity detection and potency determination of protein samples, including ELISA, BLI and SPR) * Experience in relevant sample preparation techniques including desalting, buffer exchange, proteolytic digestion, deglycosylation, reduction, alkylation, etc. * Experience in the operation, maintenance, and troubleshooting of associated instrumentation. * Ability to design and execute experiments; review and interpret data * Experience using software packages such as LIMS, ELNs, EMPOWER, SoftMax Pro, JMP, etc. is preferred. * Experience with automation and high-throughput screening desired. * Experience in the analysis of ADCs is a plus. * thirty About the Company: This is a unique and exciting opportunity with a drug and target discovery company that uses innovative synthetic biology and deep learning to expand the therapeutic potential of proteins. |
Portland, OR |
| Scientist I, Downstream Manufacturing Operations
This is an exciting opportunity with a leading, global pharmaceutical company that focuses on discovery, development, and commercialization of prescription medicines. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on patient?s lives. You will be responsible for the following activities: * Supporting commercial production and tech transfer of manufacturing processes. * Conducting process performance monitoring, conceptualizing and implementing process improvement strategies, and developing process models. * Conducting and/or participating in multiple projects that range in complexity and technical demand within a specific area/field. * Initiating, implementing, planning, directing, and executing investigations to resolve deviations, understanding process trends, and/or improving process models. * Balancing day-to-day technical support for manufacturing operations, long-term projects, and investigations. * Maintaining technical expertise on several process unit operations. * Serving as mentor and role model to other associates or lab personnel, with occasional supervision of lower-level scientists or associates. * Writing sections of regulatory documents and representing operations during regulatory inspections. Desired Skills: Minimum Requirements: * B.S. degree in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry, or related Life Sciences/Engineering field. M.S. or PhD preferred. * 4+ years of Biopharmaceutical, Pharmaceutical, or Biotechnology industry experience. * Downstream commercial support and/or purification process experience required. * Knowledge of GMP manufacturing principles and documentation. * Working knowledge of Biologics and/or relevant work experience in purification of large molecules in therapeutic antibodies, vaccines, or injectables. * Experience working cross-functionally within a BioPharma manufacturing organization. * Strong Scientific and Engineering knowledge and ability to perform downstream purification techniques. * Previous experience with statistical analysis and/or modeling (i.e., JMP, Minitab, SIMCA, and/or Discoverant a plus). * Knowledge of QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma manufacturing. * thirty About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Frederick, MD |
| Manufacturing Technology Associate II
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About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Frederick, MD |
| Reliability Engineer, Biopharma Manufacturing
This is a unique opportunity responsible for leading and driving site wide Reliability Engineering initiatives for the manufacturing of BioPharma drug substance and biologic products. It's an outstanding opportunity responsible for championing Reliability Engineering, Reliability Strategies and Predictive Maintenance programs to harmonize site-wide manufacturing processes. You will also be responsible for: * Driving and implementing Reliability Engineering, Reliability Strategies and Predictive Maintenance programs site wide. * Utilizing key reliability tools including RCA, PdM and FMEA to champion cost reductions and manufacturing improvements. * Managing predictive technologies including Vibration Analysis, thermography, Infrared Analysis and Oil Analysis to increase equipment uptime. * Developing creative solutions to achieve the highest metrics for increasing equipment uptime availabilities, performance capacities, and OEE Overall Equipment Effectiveness. * Developing plans to implement global TPM (Total Productive Maintenance) pillars involving preventative maintenance, periodic maintenance, corrective maintenance, and maintenance prevention activities to achieve zero defects, zero breakdown, and zero accidents in all functional areas of the organization. * Utilizing continuous improvement, TPM, Total Quality Management, Six Sigma methodologies, and Lean Manufacturing techniques to develop a best in class maintenance program. * Supporting capital projects and process improvements involving high volume packaging systems and food production equipment including blending systems, mixing tanks, steam injectors, spray dryers, and liquid processing tanks. * Serving in a Project Leadership role managing complex, strategic cross-functional projects for delivering Reliability Excellence across a rapidly growing biologics manufacturing site. Desired Skills: * BS or MS degree in Mechanical Engineering, Electrical Engineering, Biochemical Engineering, Chemical Engineering or related Engineering field. * 3-5+ years of experience leading and championing Reliability Engineering or Maintenance Engineering related initiatives and programs. * Experience leading manufacturing site Operational Excellence and Lean Manufacturing programs. * Expertise developing, implementing and executing RCM principal and techniques including vibration analysis, infrared thermography, oil analysis, non-destructive testing, and material chemical compatibility. * Experience implementing strategic TPM Maintenance Systems, TPM Pillars, and Maintenance master plans. * BioPharma industry or mammalian cell culture derived biologics manufacturing experience a plus. * Lean Six Sigma Green Belt, Black Belt or Master Black Belt Certification a plus. * thirty About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Frederick, MD |
| Quality Control Manager, Respiratory Therapies
This is an exciting opportunity with a leading, global pharmaceutical company that focuses on discovery, development, and commercialization of prescription medicines. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on patient?s lives. You will be responsible for the following activities: * Providing expert technical and analytical leadership, advice, and direction to the Quality Control team. * Authoring, reviewing, and revising documentation needed for cGMP manufacturing of commercial product. * Establishing visual tracking and other tools to enhance Audit readiness and trend analysis. * Overseeing completion of laboratory investigations and studies. * Leading process improvement activities and teams to meet strategic goals. * Managing schedules, attendance, vacation time, and staffing coverage for the team. * Monitoring key performance indicators to meet goals. * Performing quality audits to ensure devices used are in proper working order. * Developing and tracking the department?s budget. * Managing the performance of others, including performance/merit reviews, professional development, and disciplinary action. * Developing and communicating a vision for the unction in alignment with overall organizational goals. * Overseeing outgoing product reviews, documentation, and release. * Ensuring final products meet specifications of market to which it is being sent. * Interpreting regulations for site set in place by FDA and other Outside US regulatory authorities. Desired Skills: Minimum Requirements: * Bachelor?s degree (B.A./B.S.) in a Microbiology, Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Scientific/Engineering field. * Minimum of 7 years of relevant Quality Control, biopharmaceutical development, or manufacturing experience required. * Minimum of 3 years of supervisory or managerial experience. * Extensive experience and in-depth knowledge of GMP/GLP laboratory principles and concepts. * Strong knowledge and understanding of analytical chemistry and laboratory instrumentation. * Previous experience interacting with regulatory authorities and leading investigations. * Ability to serve as subject matter expert and/or primary point of contact for safety initiatives. * thirty About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Redwood City, CA |
| Validation Engineer, Respiratory Therapeutics
This is an exciting opportunity with a leading, global pharmaceutical company that focuses on discovery, development, and commercialization of prescription medicines. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on patient?s lives. You will be responsible for the following activities: * Performing installation and operational and performance qualification (IQ/OQ/PQ) of manufacturing equipment, facilities, utility, automated and computerized systems. * Developing and reviewing qualification protocols and reports, coordinating system and equipment documentation collection, and analyzing collected data against pre-determined criteria. * Solving qualification and validation execution issues using critical analysis skills and developing sound, reasoned solutions, and recommendations. * Working with Operating Technicians and Maintenance during fieldwork and execution of protocols. * Representing the Validation group in Change Control meetings and evaluates impact of changes to the validated state. * Ensuring that work is performed in accordance with applicable laws, industry guidelines and practices, approved procedures, and cGMP. * Performing assessments to determine if re-qualification and/or re-validation is needed in accordance with local procedures. * Maintaining and improving reliable and adaptable working relationships with internal and external customers and suppliers. Desired Skills: Minimum Requirements: * Bachelor?s degree (B.A./B.S.) in a Microbiology, Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Scientific/Engineering field. * Minimum of 1 year of relevant qualification or validation experience in the pharmaceutical industry or related work experience from scientific or technical degree. * Ability to analyze data and apply scientific principles to problem resolution. * Awareness of qualification of control systems and computer system validation. * Excellent technical writing, verbal communication, and collaboration skills. * Knowledge of and ability to read P&IDs and other technical information. * Ability to incorporate technical information into user, facility, and equipment specifications. * thirty About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Redwood City, CA |
| Sr. Automation Validation Engineer, Biologics Manufacturing
This is an exciting opportunity with a leading, global pharmaceutical company that focuses on discovery, development, and commercialization of prescription medicines. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on patient?s lives. You will be responsible for the following activities: * Providing technical support to the manufacturing and logistics buildings for protocol and testing script development. * Reviewing, testing, troubleshooting, and assessing/testing modifications and improvements to automated systems and data management systems. * Testing automated recipes, phases, and Human Machine Interface (HMIs). * Performing testing in a simulated environment (development/pre-production) or production environment. * Converting sequences of operations into detailed design specifications (DDS). * Understanding and implementing Good Automated Manufacturing Practices (GAMP) and GAMP categories. * Understanding of validation principles, including Computerized Systems Validation (CSV) and/or Computer Software Assurance (CSA). * Leading investigations, problem solving, risk assessment, and mitigation. * Leading validation assessments for proposed changes. * Serving as subject matter expert for validation planning. Desired Skills: Minimum Requirements: * Bachelor?s degree (B.A./B.S.) in Engineering, Computer Science, or another technical field. * Minimum of 2 years of relevant industry experience required for Automation Validation Engineer role. * Minimum of 5 years of relevant industry experience required for Sr. Automation Validation Engineer role. * Minimum of one year of Pharmaceutical/Bioscience experience. * Advanced understanding of validation/documentation hierarchy. * Familiarity with one or more of the following: PLC systems (specifically Rockwell Automation), distributed control systems (specifically Emerson DeltaV), management systems (specifically Siemens), and IT infrastructure. * Excellent technical writing and verbal communication skills. * Proficient in Microsoft Office. * thirty About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Frederick, MD |
| Associate Director, Site Microbiology, BioPharma Manufacturing
This is an exciting opportunity responsible for overseeing all Site Microbiology activities within a major US BioPharma manufacturing facility. You will be charged with overseeing the following activities: * Overseeing Site Quality Control Microbiology Operations within a large scale mammalian cell culture drug substance manufacturing environment. * Overseeing and providing technical leadership for advanced microbiology testing including sterility, bioburden, endotoxin and microbial identification. * Leading QC Microbiology related Manufacturing Science and technical troubleshooting activities including deviation handling, investigations, risk mitigation and microbial identification. * Overseeing cell culture contamination control programs such as mycoplasma testing, aseptic processing, environmental monitoring, gowning qualification practices, cleaning, sanitization, disinfection, sterility testing, bioburden testing and the identification of potential microbial contamination. * Leading microbial analytical method validation activities. * Overseeing the setup of new QC Microbiology laboratories and performing equipment qualification and validation. * Ensuring Microbiology related compliance and interactions with regulatory agencies including FDA & EMEA during audits and inspections. Desired Skills: * BS, MS or Ph.D. in Microbiology. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Hands-on expertise leading QC microbiology testing and assays including sterility, bioburden, endotoxin and microbial identification. * Expertise leading microbiology related investigations with successful experience resolving related deviations. * Experience interfacing with regulatory agencies including FDA & EMEA during audits and inspections * Strong Scientific expertise working within Microbiology or Quality Control laboratories testing for the generation of monoclonal antibody and recombinant protein therapeutic products. * Expertise leading microbiology related methods development, methods qualification, and methods validation activities. * Expertise working within cGMP compliance and providing GMP documentation. About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Frederick, MD |
| QC Microbiology Analyst, Biologic Therapeutics
This is an exciting opportunity with a leading, global pharmaceutical company that focuses on discovery, development, and commercialization of prescription medicines. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on patient?s lives. You will be responsible for the following activities: * Serving as lead for investigations and Environmental Monitoring. * Sampling and conducting routine and non-routine analysis of environmental samples, in process and finished products. * Sampling of WFI and purified water systems, clean steam, and compressed gases. * Testing of water and product samples including conductivity, bioburden, endotoxin, TOC and microbial IDs, growth promotion, nano filtration, A280, water analysis. * Completing appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms. * Reviewing data acquired for compliance to specifications and reports abnormalities. * Analyzing data for trending or archiving and entering data into system. * Preparing validation protocols, executing experiments, and preparing validation reports. * Writing new standard operating procedures or revising existing documentation. * Preparing documentation for presentation to Regulatory Agencies. * Calibrating, troubleshooting, and maintaining laboratory equipment as necessary. Desired Skills: Minimum Requirements: * Bachelor?s degree (B.A./B.S.) in a scientific field. * Minimum of 1+ years of relevant Quality Control experience required for QC Analyst II position. * Minimum of 3+ years of relevant Quality Control experience required for QC Analyst III position. * In-depth understanding and knowledge of testing as performed in commercial GMP QC laboratories. * Experience leading QC related technical troubleshooting including deviation handling and investigations. * Previous experience interacting with regulatory authorities and leading investigations. * Experience working in a sterile/aseptic environment is strongly preferred. * Experience working in a regulated (GxP) environment and able to participate in Quality Systems. * thirty About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Gaithersburg, MD |
| Senior Manager, Raw Materials, Biologics
This is an exciting leadership opportunity to play a key role in developing raw material control strategies and monitoring technologies for global biologics manufacturing. You will be responsible for leading cross-functional teams and harmonizing internal manufacturing organizations and CMOs. You will also be charged with the following activities: * Serving as SME on raw materials used for DS manufacturing; including, but not limited, RM specification and test methods, relevant regulations and compliance standards. * Working alongside QC/QA/R&D SMEs to maintain control strategies and monitoring technologies for pipeline programs and commercial products. * Providing technical support for external DS tech transfer teams, operational improvement projects, and process investigations across the network. * Serving as SME for alternative materials sourcing projects by evaluating alternative RMs proposed by CMO based on process needs, QC, and release lead time considerations. * Authoring global change controls related to RM specifications in the quality management system and work with internal and external sites to implement and reviewing regulatory sections related to RMs and responding to regulatory inquiries specific to raw materials. * Supporting tech transfer of DS process (upstream and downstream) into external sites, including reviewing/authoring relevant technical documents. * Identifying opportunities to implement Lean practices and improve business processes related to tech transfer, knowledge management and best practice sharing. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 6+ years of BioPharmaceutical industry experience. * Knowledge of compendia (USP/NF, Ph. Eur. and JP) and RM release test methods for raw materials, disposables, and components used in biologics manufacturing processes. * Technical and operational understanding of upstream and downstream cGMP biologics manufacturing processes to assess impact of raw materials on processes. * Experience and understanding of incoming RM quality management procedures in the industry and regulatory expectations. * Experience overseeing Quality Control and Biologics technology transfers. * Six Sigma Green Belt or Black Belt Certification a plus. About the Company: This position is within a major Global BioPharma company that is rapidly growing its development pipeline, commercial product line, and manufacturing operations. This is an outstanding opportunity work in an industry leading BioPharma company. |
Southern MD Facility, MD |
| Social Media Coordinator
This is an exciting new opportunity to work with a well established company that is fast growing, and making strides as a trend setter in the stone & tile industry. This company prides themselves on their mission of a customer-centric experience, as well as a culture that values social responsibility and employee development. This position is responsible for increasing engagements in social media and influencer marketing to drive traffic towards the retail, commercial, and wholesale space, while maintaining brand identity. You will be in charge of the following duties: Assist in the planning, strategy, and execution of social activity across all platforms (ie: Instagram, TikTok, Facebook, Twitter, YouTube, Pinterest, Snapchat, Linkedin) Work with customer service and/or appropriate cross-functional teams to promptly address any customer concerns, questions or issues Help create content for email, blog and social posts Assist in influencer partnerships Help establish and reach/meet KPIs and benchmarking Collaborate with the Director of Digital Strategy on execution of all social assets Responsible for scheduling and deploying all organic social activity across platforms Develop guidelines and apply brand editorial voice to engage with fans on social both manually responding and enabling community management system/tools Identify new opportunities for original social content, relative to industry trends. thirty Desired Skills: Desired Skills & Experience: BA in Marketing, Design, or Business (preferred, but not required) 2+ years of experience in the field of marketing and/or social media. Experience building and executing social marketing campaigns and content calendars Understanding of up-to-date design needs/restrictions on all platforms Experience with scheduling platforms Proficient in Google Analytics and Adobe Creative Suite Ability to maintain brand voice About the Company: This company is one of the largest independent porcelain tile and stone importers in the country, with nationwide and international recognition. They pride themselves on their mission of a customer-centric experience, as well as a culture that values social responsibility and employee development. |
Anaheim, CA |
| Sr. Visual Designer, Interior Design
This is an exciting new opportunity to work with a well established company that is fast growing, and making strides as a trend setter in the stone & tile industry. This company prides themselves on their mission of a customer-centric experience, as well as a culture that values social responsibility and employee development. This position is responsible for the design and assistance of print and web graphic designs under the supervision of the Marketing Manager as a part of our creative marketing team. Examples of creatives include in emails, landing pages, package design, core marketing assets and digital/ social assets. You will be required to collaborate across multiple disciplines all while maintaining high standards for original concepts and detailed execution. We want someone who can follow the established design and rules that have been created, but also understand when it?s necessary to deviate from them. You will be in charge of the following duties: ? Create print and web designs with the direction of Marketing Manager ? Print production of marketing materials that have been established ? Review designs of fellow designers to ensure creative meets design standards ? Collaborate in a team environment to develop new designs and enhance existing concepts ? Stay up-to-date on design software and design trends thirty Desired Skills: Desired Skills & Experience: ? Associates or Bachelor?s Degree in graphic design or related field ? Proficient in: ? Adobe Creative Suite ? MS Office knowledge a plus ? Mac OSX Figma ? Minimum 5 years work experience in related field ? Must have excellent understanding of design, layout, and typography principals ? Cross-platform design experience (social media, print, web, mobile, email) ? Ability to successfully manage multiple design projects and deadlines ? High attention to detail with attention to spacing, margins and alignment of graphics and typography ? Strong organizational skills ? Good communication and leadership skills ? Photography/videography skills a plus ? Tile/stone or interior design experience is a plus ? Flexible and adaptable to changes as they come About the Company: This company is one of the largest independent porcelain tile and stone importers in the country, with nationwide and international recognition. They pride themselves on their mission of a customer-centric experience, as well as a culture that values social responsibility and employee development. |
Anaheim, CA |
| Jr. Graphic Designer, Interior Design
This is an exciting new opportunity to work with a well established company that is fast growing, and making strides as a trend setter in the stone & tile industry. This company prides themselves on their mission of a customer-centric experience, as well as a culture that values social responsibility and employee development. This position is perfect for those with fundamentals of design and typography. You will be in charge of the following duties: ? Create print and web graphic designs with collaboration with the Marketing Manager ? Print/ production of marketing materials that are established by Senior Design team ? Work within a team environment to understand end-user needs and develop practical solutions ? Quality assurance of print and web designs prior to print/launch ? Stay up-to-date on design software and design trends thirty Desired Skills: Desired Skills & Experience: ? Associates or Bachelor?s Degree in graphic design or related field ? Proficient in: ? Adobe Creative Suite including Photoshop, Illustrator, InDesign ? MS Office knowledge a plus ? Mac OSX ? 1-3 years work experience in related field ? Must have excellent understanding of design, layout, and typography principles ? High attention to detail with attention to spacing, margins and alignment of graphics and typography ? Strong organization, time management, and communication skills ? Flexible with changes ? Tile/stone or interior design experience is a plus About the Company: This company is one of the largest independent porcelain tile and stone importers in the country, with nationwide and international recognition. They pride themselves on their mission of a customer-centric experience, as well as a culture that values social responsibility and employee development. |
Anaheim, CA |
| Scientist/Lead Scientist, Small Molecule Analytical Development
This is an exciting new opportunity to join an established and expanding San Diego site of an industry leading Contract Research and Contract Manufacturing organization. You will be responsible for leading and mentoring a small team driving analytical methods development activities for the development of novel small molecule therapeutics and APIs. Your overall responsibilities will also include: * Leading and mentoring team members of Scientists, Associates and Chemists responsible for the development and validation of a variety of Pharmaceutical forms. * Applying scientific expertise for identifying best solutions for analysis of small molecule therapeutics and APIs in various forms including tablets, capsules, powders, suspensions and spray dry. * Leading the development and qualification of analytical methods for the evaluation, testing and support of new product development efforts for stability, potency, water content, forced degradation and excipient compatibility studies. * Serving as a Lead Scientist/Technical Lead in direct client communications and project team meetings. * Developing, transferring and troubleshooting analytical methods to client sites. * Developing analytical methods utilizing HPLC, UPLC, dissolution, GC, MS and NMR for use in release, stability testing and degradation studies for small molecule samples and clinical materials. * Leading the analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to assigned specifications, Critical Quality Attributes, methods and protocols. Desired Skills: * BS or MS or in Pharmaceutics, Pharmaceutical Technologies, Formulations, Biochemistry, Chemistry or related Scientific field. * 5+ years of Pharmaceutical, Biotechnology or BioPharmaceutical industry experience. * Scientific mentoring and leadership experience. * Experience in the design, development, optimization, qualification, and transfer of analytical methods utilizing HPLC, UPLC, dissolution, GC, MS and NMR techniques. * Experience working within GLP and cGMP compliance. * Scientific & Technical leadership experience developing small molecule therapeutics in various forms. * thirty About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site. |
San Diego, CA |
| Manager mRNA BioPharmaceutical Manufacturing
This is an exciting new opportunity to lead mRNA BioPharma manufacturing operations within an expanding best in class Midwest based mammalian cell culture biologics CMO with an extensive network of cGMP facilities and major global BioPharma clients. It's also an exciting opportunity to lead major growth efforts due to new client acquisitions and facility expansion projects. You will be charged with overseeing the following activities: * Managing a team of supervisors and total staff of 10-15 people within a multi-shift mRNA & Molecular Therapeutics Manufacturing team. * Leading cGMP manufacturing including master/working cell bank production, upstream mammalian cell culture, downstream protein purification, mRNA purification and Drug Product Fill/Finish. * Serving as a key team member for leading commercial Pre-Approval Inspections (PAIs) and interacting with Global regulatory agencies. * Implementing lean manufacturing techniques, process improvements, and electronic batch record systems. *Delegate responsibilities to complete required documentation of reports, tasks, and others related to operations. *Review and approve executed manufacturing MBRs and ensure errors are correct during manufacturing=g operations * Ensuring compliance with cGMPs, SOPs safety procedures and FDA regulations. Desired Skills: * BS or MS degree in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field. * 7+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Excellent management and leadership experience. * mRNA Vaccine or mRNA Therapeutic manufacturing or process development experience. * Strong Scientific, Engineering, and Manufacturing expertise managing upstream mammalian cell culture, downstream protein purification or mRNA purification manufacturing for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise engineering and operating upstream or downstream processing equipment including cell banking, bioreactors, filtration, chromatography skids, TFF, AKTA, UNICORN and/or HPLC systems. * Expertise leading scale-up, technology transfer and process validation (PQ) activities. * Experience working with DeltaV automation systems a plus. * Expertise working within cGMP compliance and providing GMP documentation. About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site. |
Chicago, IL |
| Principal Scientist, Biologics Analytical Development
This is an exciting new opportunity to work within an expanding US Biologics Contract Manufacturing Organization with an extensive network of cGMP facilities. It's also an exciting opportunity to lead major growth efforts due to new client acquisitions and facility expansion projects. This is a unique scientific leadership opportunity charged with driving therapeutic antibody drug development efforts utilizing advanced bioassays, immunoassays and cell based assay methods. Your overall responsibilities will also include:
* Driving the development of state-of-the-art bioassays, immunoassays, and cell based assays for analytical methods implementation, validation, qualification, technology transfer, and protein characterization activities. * Driving bioassay development efforts for cell based assays, functional assays and immunoassays including target binding assays, proliferation assays and Fc effector function reporter assays. * Developing and leading biological characterization strategies for monoclonal antibody therapeutics from R&D stages, IND stages through to BLA and commercialization. * Leading contributions to CMC sections of regulatory filings including IND, NDA, and BLA submissions. * Leading assay optimization, validation and transfer of validated bioassay methods to CROs and commercial QC laboratories. Desired Skills: * MS or Ph.D. in Immunology, Cell Biology, Molecular Biology or related Life Sciences field. * 7+ years of BioPharma industry experience developing biologic therapeutics including recombinant proteins, monoclonal antibodies, antibody drug conjugates or fusion protein drug products. * Experience leading Scientists developing and validating bioassays, cell-based assays and immunoassays including ELISA, Biacore, SPR, ADCC or CDCC assays. * Exceptional Scientific leadership experience. * Expertise developing advanced potency assays, functional assays, structural assays, proliferation assays and binding assays. * Drug Development experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired. * Experience working on technology transfer and validation activities. * Experience supporting Commercial QC analytical test methods and working within GMP/cGMP and GLP compliance. About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site. |
Mc Farland, WI |
| Sr. Scientist, Analytical Methods Development
This is an exciting Scientific Project Leadership opportunity responsible for overseeing the development, qualification, validation and technology transfer of analytical methods from early stage biologics development through to commercialization. You will also be charged with overseeing technology transfer activities of analytical development and testing activities with CDMO partners. You will also be charged with overseeing the following activities: * Driving the technical oversight and development, qualification, validation and transfer of chromatographic, electrophoretic, and immunological methods targeted for in-process, release, and stability testing of early and late stage monoclonal antibody & protein therapeutic development programs. * Leading analytical methods qualification, methods validation activities and tech transfer activities with external contract manufacturers and CDMOs. * Preparing and reviewing documents in support of CMC regulatory submissions and writing responses to health authority questions. * Driving and leading stability studies, data trending, detection and reporting of trends and investigations in response to unusual or unexpected deviations. * Leading root cause analysis and unexpected results (OOS/OOT) investigation procedures and training staff members on best practices. * Partnering and interfacing with CMC operations and Quality Assurance team members to influence product characterization, QC testing, and regulatory strategies. * Providing expertise and technical leadership for troubleshooting product quality deviations impacting non-conformance and out of specification investigations. Desired Skills: * MS, or Ph.D. in Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Life Sciences field. * 6+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience preparing, writing and contributing to CMC regulatory filings. * Experience partnering and working with External CMOs for analytical tech transfer activities. * Experience leading QC stability, degradation and comparability studies. * Expertise in DOE, QbD (Quality by Design), data analysis and statistical modeling. * Knowledge and expertise in analytical testing, analytical methods development, and characterization including HPLC, UPLC, Capillary Electropheresis, SEC, CEX, RP, HIC and other modern protein separation techniques. * Strong understanding of drug development processes and related GMP global regulations. About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site. |
Mc Farland, WI |
| Manager Downstream Purification, BioPharma Manufacturing
This is an exciting new opportunity to work within an expanding best in class Midwest based mammalian cell culture biologics CMO with an extensive network of cGMP facilities. It's also an exciting opportunity to lead major growth efforts due to new client acquisitions and facility expansion projects. You will be charged with overseeing the following activities: * Leading cGMP downstream protein purification commercial manufacturing activities ranging from harvest, filtration, chromatography, viral clearance and recovery. * Managing a team of supervisors and total staff of 50+ people running downstream purification studies, process validation activities, and process characterization activities of monoclonal antibody and recombinant protein products. * Serving as a key team member for leading commercial Pre-Approval Inspections (PAIs) and interacting with Global regulatory agencies. * Implementing lean manufacturing techniques, process improvements, and electronic batch record systems. *Delegate responsibilities to complete required documentation of reports, tasks, and others related to operations. *Review and approve executed manufacturing MBRs and ensure errors are correct during manufacturing operations * Ensuring compliance with cGMPs, SOPs safety procedures and FDA regulations. Desired Skills: * BS or MS degree in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field. * 7+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Excellent management and leadership experience. * Strong Scientific, Engineering, and Manufacturing expertise managing downstream protein purification manufacturing for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise engineering and operating downstream processing equipment including filtration, chromatography skids, TFF, AKTA, UNICORN and HPLC systems. * Expertise leading scale-up, technology transfer and process validation (PQ) activities. * Expertise working within cGMP compliance and providing GMP documentation About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site. |
Chicago, IL |
| Associate Director/Principal Engineer, MSAT Specialist, BioPharma Manufacturing
This is an exciting new opportunity responsible for leading Manufacturing Sciences & Technology (MSAT) related activities for large scale clinical and commercial recombinant protein manufacturing. This is an exciting new opportunity to work within an expanding US Biologics Contract Manufacturing Organization with an extensive network of cGMP facilities in the US, Europe and Asia. It's also an exciting opportunity to lead major growth efforts due to new client acquisitions and facility expansion projects. Your roles and responsibility will include: * Leading MSAT projects relating to upstream mammalian cell culture and downstream purification manufacturing operations. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing subject matter expertise relating to CAPAs, manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to upstream cell culture related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Serving as a technical/scientific Subject Matter Expert for upstream cell culture activities ranging from vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations. * Serving as a technical/scientific Subject Matter Expert for downstream protein purification activities ranging from column chromatography, filtration (UF, DF, TFF), harvest and recovery. * Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Training staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings. * Assisting in the build-out of BioPharma Automation Systems, Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5-10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments. * Strong Scientific and Engineering technical experience performing either upstream cell culture or downstream purification manufacturing activities * Upstream or Downstream expertise involving any of the following activities: vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations, column chromatography, filtration (UF, DF, TFF), harvest and recovery for the manufacturing of recombinant protein and monoclonal antibodies. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma. About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site. |
Chicago, IL |
| Sr. Scientist, Mass Spec
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About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics. |
Shrewsbury, MA |
| Sr. Scientist, Analytical
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About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics. |
Shrewsbury, MA |
| Scientist I, Analytical
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About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics. |
Shrewsbury, MA |
| Project Manager, In Vivo Biosafety I
This is an exciting opportunity with a leading, early-stage contract research organization (CRO). You will serve as study director for GMP studies, responsible for technical review of data and report compilation. In addition, you will be charged with the following activities: * Assuring that study or assay protocols, including any changes, are approved and followed. * Maintaining accurate and verified records of all experimental data. * Recording any unforeseen circumstances that may affect the quality and integrity of the study and taking corrective action when needed. * Testing systems, including reagents, live cells, equipment, etc. as specified in the protocol. * Performing technical review of study data and ensuring that studies are conducted accurately, efficiently and in compliance with cGMP regulations. * Transferring all raw data, documentation, protocols, specimens, and final reports for archiving during or at the close of the study. * Mentoring and training staff in areas such as protocol, data interpretation, and project related problem resolution. * Routinely interacting with technical and Quality Assurance staff to ensure compliance to departmental SOPs, protocols, and cGMP regulations. * Coordinating interactions with other work groups as it pertains to study procedures. * Interacting with clients regarding sample submission, scheduling, execution, and reporting. * Participating in the creation and revision of protocols and SOPs associated with cGMP testing, including standard and customer specific protocols. Desired Skills: Minimum Requirements: * Bachelor?s degree (B.A./B.S.) or equivalent in a technically related discipline with 5-7 years related technical experience. * Ability to move about regularly inside the laboratory, communicate and operate a computer. * Must be able to lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. * Previous experience using personal protective equipment (PPE) while performing laboratory duties. * Vision abilities required: close vision, distance vision, color vision, depth perception, and the ability to adjust focus. * Experience working in a busy research environment with sharp objects, mechanical parts, working with or near known or unknown toxic chemicals and/biological hazards, and exposure to fumes and airborne particles. * Experience working with biological samples with risk of exposure to zoonotic disease and biohazards. * Position may require some domestic travel. * thirty About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics. |
Boston, MA |
| Manager, Computer Systems Validation, BioPharma
This is an exciting opportunity responsible for driving and leading Computer Systems Validation activities within a leading Biologics testing and manufacturing organization. You will be responsible for providing quality oversight, qualification, validation and verification deliverables of laboratory instrumentation software systems and change control for software modifications. Your roles and responsibilities will also include: * Leading and Managing laboratory Computerized Systems Validation activities which align with FDA regulations and industry accepted best practices. * Driving and leading CSV Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IV/OV/PVT), Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Periodic Compliance Reviews and Validation Summary Reports. * Leading computer systems and Automated Process Control validation studies including protocol preparation and protocol execution. * Leading Periodic Compliance Reviews for Computer Systems/Equipment to include change control activities. * Assisting with external audits to support CSV vendors. * Leading teams to refine and harmonize computerized systems qualification processes and templates. * Supporting CSV of Electronic Quality Management Systems (EQMS) and Laboratory Information Management Systems (LIMS). * Performing cGMP and GMP documentation activities writing SOPs and providing documentation within cGMP compliance. Desired Skills: * Bachelors degree in Computer Science, Engineering, Biochemical Engineering, Chemical Engineering, Mechanical Engineering, Biochemistry, Biology or related Engineering or Life Sciences field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * BioPharma industry experience leading Computer Systems Validation (CSV) activities within laboratories for laboratory instrumentation and LIMS. * Expertise working with Quality Management Systems and plant initiatives including Electronic Data Management Systems (EDMS), Electronic Quality Management Systems (EQMS) and Laboratory Information Management Systems (LIMS). * Expertise working within cGMP compliance and familiarity with 21 CFR 210, §211, and Part 11, GAMP5, EudraLex Annex 11 Volume 4 -Computerized Systems regulations. About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics. |
Wayne, PA |
| Associate Director, Quality Control Biologics Testing
This is an exciting opportunity responsible for overseeing Quality Control functions within a leading Biologics testing and manufacturing organization. You will be responsible for providing technical guidance to staff, scientists in quality control related departments including Analytical, Biophysical, Bioassay and/or Mass Spectrometry. You will also be responsible for the following activities:
Desired Skills:
*THIRTY About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics. |
New York, NY |
| Director, Biologics Training
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About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics. |
Wayne, PA |
| General Manager, Low Acid Aseptic Sciences and Manufacturing
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About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| Sr Scientist/Project Leader/Director, Plant-Based Functional Foods
This is an exciting entrepreneurial leadership opportunity within an ultra-innovative category defining plant-based food & beverage, functional foods and nutritional products company with new research labs and expansive growth plans. You will be charged with overseeing new product development & innovation for a new line of vegan plant-based dairy alternatives and functional foods from product launch through to commercialization. Your overall roles and responsibilities will include: - Overseeing Product Development and Innovation to introduce and grow non-dairy food & beverage products including sour cream, cream cheese and yogurt products and category defining all natural plant-based dairy food alternatives. - Innovating and developing new plant-based functional food and beverage products seeking inspiration from successful International brands within the Japanese, Korean or Asian markets such as smoothies, drinkable ice cream, lactic pouch drinks, pouch jelly drinks and functional sports beverages. - Partnering with marketing, scientific and technical core team members to define project scope, success criteria, and critical paths while maintaining Stage Gate methodologies from innovation, R&D, process scale up, sensory testing, product launch through to successful completion of post-launch reviews. - Understanding and leveraging the nutritional impact value of functional food products, interpreting results and working with Marketing to further product development efforts. - Driving Scientific Marketing campaigns through content creation, PR campaigns and writing for scientific whitepapers and informational documents. - Driving the success of Business Operations through forecasting, budgeting, P&L accountability, development of KPIs and e-commerce analytics. - Serving as member of the company?s leadership team overseeing and developing the emerging Health and Nutrition Science Division. Desired Skills: - 3+ years of successful product development and marketing experience from within plant-based foods, functional foods, dairy alternative, meatless foods, nutritional products, nutraceutical, infant formula, toddler products and or food-pharma related industries. - MS or Ph.D. in Food Science, Nutritional Science, Nutrition or related scientific field. MD or MBA a plus. - Experience developing or commercializing food and beverage brands in Asia including Japan or South Korea markets such as smoothies, drinkable ice cream, lactic pouch drinks, pouch jelly drinks and functional sports beverages. - Scientific expertise developing and commercializing non-dairy sour cream, cream cheese and yogurt products. - Successful experience building early stage natural foods, functional foods, organic foods, plant-based foods, nutraceutical, nutritional products and non-dairy alternative brands into category market leaders. - Project Management experience developing nutritional food products from discovery, R&D, development, product launch through to commercialization phases. - Process Innovation expertise working with aggressive Stage-Gate methodologies. - Scientific lab expertise working with functional foods, plant-based foods, nutritional ingredients, flavor chemistry, nutritional food components, emulsions or sensory science a plus. - Strong publication, presentation and patent record. - Experience working within FDA, GMP, HACCP and FOSHU (Food for Specified Health Uses) regulations. - Entrepreneurial, visionary and strategic leadership experience with the ability to work within a dynamic fast paced ultra innovative environment. - Thirty About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| Chief Operations Officer, Complex Food Sciences and Manufacturing
This is a unique C-Level leadership growth opportunity within the US?s largest low acid aseptic beverage Research, Development and Manufacturing operation. You will oversee company operations including major manufacturing partnerships with the world?s largest and prestigious food & beverage companies. Company operations also include an emerging portfolio of plant-based branded products. This is a unique opportunity to lead highly technical low acid aseptic Development and Manufacturing Operations with recent plant capital improvements and a new R&D Innovation Center. You will be charged with overseeing the following activities: * Directing the strategy of a 600+ person company to ensure the attainment of revenue and profit goals with responsibility for profit & loss and the achievement of current and long-range objectives. * Driving site operational effectiveness through a passion for excellence, investment in customer success, delivery of innovative manufacturing solutions and collaboration among departments. * Developing the vision and direction of the low acid aseptic beverage manufacturing and operational strategy in conjunction with the company?s long-term vision. * Overseeing the management of all areas of business operations including Manufacturing, Supply Chain, Quality, Engineering and R&D Innovation Center producing company owned Elmhurst branded products and customers? products manufactured on-schedule within quality standards and cost objectives. * Working alongside Business Development, Sales and Marketing teams to ensure continuation and growth of revenue generation through selling of branded products, R&D, Scientific Development and Manufacturing capabilities for the manufacturing and packaging operations. * Developing and implementing strategic supply chain plans and cold chain processes supporting low acid aseptic manufacturing operations. * Directing the scheduling of manufacturing operations and key manufacturing personnel while working within cGMP, HACCP and ISO compliance and meeting quality standards. * Coaching, mentoring, and managing manufacturing and Quality teams/staff through a Shared Leadership initiative and by establishing performance standards, evaluation of performance, employee recognition and determining employee responsibilities. * Driving the reduction of Cost of Goods through budgetary, financial and logistical management while ensuring the highest level of Quality and Regulatory Compliance. * Driving the success of 9 figure company owned real estate properties furthering the development of leasing and development partnerships. Desired Skills: * Ph.D. in Food Science, Biology, Chemistry, Microbiology, Chemical Engineering or related Scientific/Engineering field. MBA Preferred. * 15-20+ years of successful GMP regulated Pharmaceutical, Biotechnology or low acid aseptic foods operations and manufacturing leadership experience. * Entrepreneurial, visionary and strategic team leadership experience with the ability to work within a dynamic fast paced ultra innovative team environment. * Exceptional Business Operations and Financial Management expertise with demonstrated P&L oversight, forecasting, budgeting and accounting experiences. * Excellent demonstrated technical skills to understand low acid aseptic beverage or pharmaceutical manufacturing processes, including knowledge of microbiology, biotechnology and biochemistry principles. * Operations leadership experience overseeing corporate real estate development projects, plant expansions, manufacturing capacity improvements, and supply chain operations. * Lean Manufacturing, Continuous Improvement and Lean Manufacturing expertise. * Experience working within FDA, GMP, HACCP and ISO compliance. About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| LIMS Quality Control Manager, Cell Therapies
This is an exciting new opportunity responsible for driving the development, configuration, validation and maintenance of LIMS for QC Analytical and QC Microbiology testing functionalities for novel immunotherapies and cell therapies. Your roles and responsibility will include: * Overseeing the development, configuration, validation and maintenance of LIMS for QC Analytical and QC Microbiology testing, environmental monitoring, raw materials, stability and sample management functionalities. * Ensuring LIMS are in compliance with regulatory requirements and commitments for clinical and commercial products. * Serving as a QC Systems Business Owner and Subject Matter expert on LIMS/ELN configuration and processes including with Labware, MODA, Empower and LabVantage systems. * Driving QC Systems initiatives in efforts to maximize efficiency, harmonize QC business processes, and increase productivity to enable scalable laboratory operations. * Supporting product stability programs including the generation of stability protocols in LIMS, and support as needed accessing final reporting or trending of stability data. * Driving the development and implementation of LIMS by partnering with IT and external vendors. * Managing enhancements, incident investigation, and changes for a multi-site global LIMS environment. * Drafting program related support documents including operational SOPs, Work Instructions, System Impact assessments and change controls. Desired Skills: * BS or MS in Biochemical Engineering, Computer Science, Computer Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience in the administration, configuration and implementation of LIMS including Labware, MODA, Empower and LabVantage Quality systems. * Experience in systems design and the definition of business processes for LIMS including Labware, MODA, Empower and LabVantage Quality systems. * Experience working with MS SQL Server or Oracle databases a plus. * Experience leading projects relating to Quality Systems, QC system design, manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Project Management expertise managing change management, IT QC systems implementation schedules and systems validation activities. * Expertise or working knowledge of cell and gene therapy products a plus. * thirty About the Company: This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.
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Philadelphia, PA |
| Manager, Quality Control (Raw Materials)
This is an exciting new opportunity within a growing, late-stage cancer immunotherapies development company. You would be responsible for oversight and management of the Quality Control Raw Material Program. Your roles and responsibility will include: * Sampling, testing, and inspection of all raw material lots used to manufacture on site. * Knowledge of health authority expectations for novel and complex oncology programs. * Overseeing and managing the raw material schedule to align with facility production. * Ensuring adequate training within Quality Control Raw Materials group. * Serving as the lead for investigations of out-of-specification test results, corrective actions, and verification of effectiveness. * Managing on-time closure of all quality events and tasks associated to raw material release. * Supporting problem solving for technical issues pertaining to raw materials testing and release. * Authoring, reviewing, and approving SOPs, protocols, reports, specifications, and other quality control documents as needed. * Promoting continuous improvement strategies for the QC Raw Material group and implementing processes for performance management. * Operating at a consistent and exemplary level of efficiency, producing high quality and accurate results in a fast-paced environment. Desired Skills: * BS or MS in Microbiology, Biochemistry, Biology, or another related Biological Sciences field. * 8+ years in a cGMP regulated setting, including 4+ years in raw materials testing and release. * Strong analytical and technical background in compendial testing and related equipment, including wet chemistry, FT-IR, UV/VIS, KF, titration, and GC methodologies. * Experience leading and facilitating quality events, including OOS investigations. * Strong technical background and familiarity with laboratory control operations and quality systems. * Experience with inspections/audits by FDA and other regulatory agencies. * Experience with method validation and assay transfer. * Experience with lab and data management systems (i.e., LIMS, Empower, Phenix). * Expertise or working knowledge of cell and gene therapy products a plus. * thirty About the Company: This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.
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Philadelphia, PA |
| Senior Scientist, Analytical Development, Cell Therapies
This is a stellar opportunity to lead projects for Clinical Trials and Commercial supply of gene modified cellular product within an expanding US BioPharma company. You will be responsible for designing, developing, executing, and analyzing immunological assays to characterize the function and safety of modified gene cellular product. Your responsibilities will also include: * Developing pre-clinical packages for IND submission for cell and gene therapy products. * Employing analytical strategies for the assessment of genetic modification of human T-cells and receptors. * Developing and performing analytical methods for characterizing genomic editing efficiency and translocation of primary T lymphocytes using immunological and molecular assays including flow cytometry, PCR, ddPCR, and next generation sequencing methodologies for the detection of ON/OFF-target chromosomal aberrations and safety. * Supporting execution of external work during all aspects of planning and execution of outsourced activities by CROs. * Leading experimental design and organizing experimental execution. * Leading development studies and the qualification of assays involving a variety of protocols and techniques. * Implementation, troubleshooting, and analysis of molecular and cellular biology techniques. * Authoring protocols and associated reports per GDP. * Investigate and develop new methods and technologies necessary to project advancement. * Ensuring compliance and maintenance of lab safety, environment, and quality. Desired Skills: * PhD with 5+ years of industry experience in Cell and Gene Therapy with a focus in Immunology/Molecular Biology field. * Solid understanding of Immunology, particularly as it relates to Cell Therapy development. * Extensive analytical experience in molecular assays for measuring gene editing efficiency and safety such as NGS, PCR, and ddPRC. * Expertise working with Flow Cytometry including multi-color flow cytometry analytical methods and familiarity with FACS including FACSLyric. * Prior experience developing and supporting cell therapy manufacturing processes. * Required research background in immunology and/or oncology. * Knowledge and understanding of cGMP, ICH, and pharmacopeia regulations and guideline documents required. * Ability to critically think to evaluate requirements and effectively communicate findings orally as well as in writing. About the Company: This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.
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Tampa, FL |
| MSAT Manager, Cell Therapies Manufacturing
This is an exciting new opportunity responsible for leading Manufacturing Sciences & Technology (MS&T) related activities for novel cell therapy manufacturing and process development advancements. Your roles and responsibility will include: * Leading MSAT projects related to cell therapy manufacturing process improvements and deviation resolutions. * Developing and implementing manufacturing strategies for resolving complex issues and deviation resolutions for manufacturing investigations and process improvements. * Developing and executing investigation plans, protocols and reports for root cause analysis. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing subject matter expertise relating to upstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to upstream cell culture related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Serving as a technical/scientific Subject Matter Expert for aseptic manufacturing and cell culture activities ranging from production in shake flasks, T-flasks, hyper flasks, cell stacks and bioreactors. * Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Training downstream staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings. Desired Skills: * BS or MS in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments. * Strong Scientific and Engineering technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, aseptic manufacturing and cell culture activities in shake flasks, T-flasks, hyper flasks, cell stacks and bioreactors. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma. * thirty About the Company: This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.
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Philadelphia, PA |
| BioPharma Recruiter
The is a unique opportunity as a Next Generation Recruiter to apply innovating and modern approaches within the cutting edge BioPharma Industry. We provide an exciting opportunity to progress your career within an established recruiting operation. Your roles and responsibilities will include: - Recruiting and filling positions with leading companies locally, nationwide and globally within growth and niche market segments, specifically Life Sciences, Biotechnology/BioPharma/Pharma IT, Information Technology, Medical Device and Complex Foods industries. - Establishing your own solid base of industry leading clients. We provide you with unique tools to help you prospect and establish relationships with top companies! - Managing a full-life-cycle recruiting desk from establishing relationships with market leading companies, generating job orders, sourcing/recruiting candidates, closing deals, and maintaining/nurturing relationships to generate future placements. - Developing and implementing innovative and unique candidate sourcing and recruiting strategies. A few examples involve targeting candidates through our ResuWe database, publications, conference abstracts and LinkedIn. - Running your desk through our established state-of-the-art web based ResuWe Applicant Tracking System (ATS) which posts jobs, scores & ranks incoming candidates, submits candidates to clients, searches a large candidate database, and helps you pinpoint the right candidates quickly for each job requirement. - Promoting your own recruiting brand and company marketing through LinkedIn and blog posts. Desired Skills: - 1-5+ years of successful agency recruiting experience. - Exceptional Sales, Business Development and Client Management expertise with proven success prospecting, establishing clients and generating new business. - Exceptional online skills with experience and efficiency managing email correspondence, LinkedIn correspondence and online search tools. - Ability to instantly build a positive good report and relationships with candidates and clients. - Success managing your own full-life-cycle recruiting desk with the ability to prioritize recruiting efforts, maintain an organized system, and produce consistent recruiting metrics (job orders, sendouts/interviews, placements) - Creative ability to develop and implement unique candidate sourcing and recruiting strategies. - Exceptional negotiation skills working with candidates and clients while maintaining strong professionalism and high ethics. - Recruiting expertise specializing in filling technical and scientific related positions including Life Sciences, Biotechnology/BioPharma/Pharma IT, Information Technology, Medical Device and Complex Foods industries role a plus. - Ability to speak a foreign language a huge plus. We recruit globally so the ability to speak Korean, Japanese, Mandarin, Cantonese, Spanish, Portuguese, French or German will be great! About the Company: Laguna Source is a specialty search firm placing Engineering, Scientific and Quality leaders and professionals within the Biotechnology, BioPharmaceutical and Food & Nutrition industries. We recruit Scientists, Engineers, Directors and Managers within the fields of Molecular Biology, Protein Engineering, Biologics Manufacturing, Process Development, Upstream Cell Culture, Downstream Protein Purification, Pharmacology, Clinical Development, Data Management, Immunology, Oncology, Computational Chemistry, Bioinformatics, Biostatistics, Biochemistry, Quality Assurance, Quality Control and Regulatory Affairs. |
Aliso Viejo, CA |
| Supervisor, Facilities & Engineering
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About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19. |
Houston, TX |
| Quality Control Project Lead, BioPharma Manufacturing
This is a stellar opportunity within an established and thriving BioPharma company. The company is seeking a highly motivated and experienced individual to support and lead the Quality Control (QC) department via the technology transfer process, representing the department on project teams, and providing technical support during investigations. Your responsibilities will include: * Participating in the initial assessment of new products and processes. * Providing input to program management regarding QC capabilities and requirements for method qualification/validation. * Reviewing applicable regulatory guidance and internal policy documents to ensure compliance. * Providing technical review of Statements of Word (SOWs) to support contract manufacturing activities. * Writing, reviewing, and/or approving Test Records/Forms, Sampling Plans, and Specifications. * Leading tech transfers activities related to QC including generation of a QC master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines. * Working in cooperation with BioAnalytical Services to design qualification and validation protocols. * Performing QC assessment of new raw materials required to support GMP manufacturing and testing. * Assisting with responses to audits, deviations, out of specification (OOS) investigations, and corrective/preventive actions (CAPA). Desired Skills: Minimum Requirements: * B.S. in Life Science, preferably in Microbiology/Biology. * Experience with method validation and technology transfer required. * Knowledge of biological cell-based assays such as proliferation/cell count and viability, flow cytometry, ELISA, and PCR preferred. * Prior experience working with cell or gene therapy products. * Able to develop and deliver training programs for specialized and advanced activities. * Knowledge and working experience of cGMP. * Knowledge of SAP and TrackWise systems a plus. * Skilled at establishing clear and understandable directions and goals. Ability to escalate roadblocks to project/task completion. * Ability to communicate status, needs, forecasts, risks, and timelines effectively to management. * Champions change, speaking positively to and about situations and other team members. * thirty About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19. |
Houston, TX |
| Mgr/Senior Manager, Regulatory Affairs CMC (Drug Substance/Adjuvant)
This is a stellar opportunity within an established and thriving biotechnology company. Seeking a highly motivated and experienced individual for a manager/senior manager position in Regulatory Affairs CMC. You will work in close collaboration with the Associate Director Regulatory Affairs CMC to implement and coordinate all aspects of regulatory activities. Your responsibilities will include: * Assisting with CMC regulatory submission strategies pertaining to the Matrix-M adjuvant. * Managing key regulatory CMC activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, including CTAs, INDs, IMPDs, BLAs, DMF amendments, meeting requests, briefing packages, and responses to regulatory agencies. * Ensuring that overall regulatory project timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory submissions. * Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project life cycle, to project teams and appropriate management levels. * Communicating and coordinating with relevant functional groups and project team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions. * Serving as the primary CMC regulatory representative on multiple concurrent projects to ensure that activities support and comply with the relevant regulatory requirements. * Maintaining up to date knowledge on relevant regulations, guidance, and current regulatory environment. *Providing updated information on regulatory CMC issues to project teams and other personnel. Desired Skills: Minimum Requirements: * Bachelor?s in a biological science or related discipline. Advanced degree desirable, but not required. * A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC. * Experienced in vaccine development, with in depth knowledge of development processes. * Experience with post-approval changes (variations and supplements). * Good understanding and experience with current GMPs and regulatory expectations for investigational products, post-approval lifecycle management, and clinical trials. * Experience with CTD format and content. * Excellent troubleshooting skills, ability to work in a fast-paced and dynamic environment with changing priorities, and strong communication skills. * thirty About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Senior Director, Regulatory Affairs (Nonclinical/Clinical)
You will be working primarily on COVID-19 Vaccine development, functioning as a country/regional lead. The position will work in close collaboration with Regulatory Affairs and cross-functional teams, through licensure and beyond. You will be responsible for performing the following activities: * Leading the planning, oversight, management, and execution of BLAs/MAAs and their amendments/variations to support vaccine development both pre- and post-licensure, including developing strategies for indication expansion. * Leading and executing regulatory activities and critical review of documents necessary to support regulatory submissions, including INDs/CTAs, BLAs/MAAs and amendments/variations, meeting requests, briefing packages, responses to queries from regulatory agencies, etc. * Reviewing clinical/nonclinical documents for compliance with regulatory requirements, alignment across documents, and to ensure specific requests from regulators are addressed, as applicable. * Ensuring project timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory submissions globally. * Communicating and coordinating with relevant groups to identify and ensure the preparation of required documentation and data needed for regulatory submissions. * Maintaining vendor oversight and providing guidance to Safety Scientists in the collection and assessment of safety data from a variety of sources including published literature, aggregate reports, clinical studies, and other sources. * Enabling the preparation of safety analyses, signal evaluation reports, health authority response documents, and ad-hoc safety reports. * Understanding current industry practices and builds in-depth knowledge of global pharmacovigilance regulations related to the surveillance and signal management activities. Desired Skills: Minimum Requirements: * Bachelor?s degree in a scientific field; MS or PhD desirable. * Minimum of 15+ years of related experience in biotechnology industry with at least 12 years in Regulatory Affairs. Background in vaccine or biologics development; expert knowledge of the vaccine development process is highly desirable * Solid understanding of the drug development process, including experience with developing regulatory strategies for investigational products leading to licensure; experience leading at least 1 BLA or MAA is desired * In-depth knowledge of ICH, GCP, GLP, and other global regulatory requirements applicable in both the pre- and post-licensure setting. * Ability to work independently, in a group, and effectively communicate across cross-functional departments. Solid communication skills, critical thinking and ability to recognize and solve problems. * Advanced Microsoft Word skills. * thirty About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Director, Regulatory Affairs(Nonclinical/clinical)
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Administrative Officer, Korean Operations
This is an opportunity to be part of a leading IP technology provider for AI computing. We are seeking a self-motivated, dedicated, and accomplished Administrative Officer to join our team. The individual will play provide administrative support to ensure efficient operation of the office. In addition, the candidate will be responsible for: * Receiving and processing communication channels, including email, phone, and physical mail. * Assisting HR department (HQ & local) with payroll, on-boarding programs, and personnel databases. * Assisting the finance department (HQ & local) with payments, recording daily transactions, financial audits, budget management. * Managing office supply stock and placing orders when necessary. * Ensuring functionality of necessary office equipment and requisitioning new equipment and supplies as needed. * Helping in organizing events, including ordering materials and requisitioning meeting spaces. Desired Skills: * Minimum of 4 years of administrative experience. College degree not required. * Professional fluency in both English and Korean. * Proven experience working in an office environment. * Proficiency in all Microsoft Office applications. * Proven ability to multi-task. * Strong communication skills and willingness to make phone calls, send emails, and other forms of communication with clients. * Comfortable working independently or as part of a team. * thirty About the Company: This is an exciting opportunity with a leading semiconductor IP technology provider for AI computing, empowering the Internet of Smart Things. |
San Jose, CA |
| Manager, Food Safety and Quality Compliance, Nutritional Food Products
This is an exciting opportunity responsible for ensuring a broad set of Quality Assurance activities for the successful manufacturing of complex dairy, nutritional foods, and low acid retort products. Your overall Quality Assurance responsibilities will include: * Leading internal audits and compliance initiatives to ensure internal departments including Quality Control, Quality Assurance, Production, Manufacturing, Food Safety, Warehouse, Distribution, Procurement, Information Technology, and Research Development departments operate within cGMP and HAACP Compliance. * Overseeing sanitation and hygiene compliance programs. * Leading internal audits and inspections within global company-wide international manufacturing facilities. * Implementing corrective actions utilizing Six Sigma methodologies, Lean Manufacturing techniques and Continuous Improvements. * Performing investigation and troubleshooting activities with regards to spray dry, powder processing, and microbial contamination processes. * Interact directly with FDA and other regulatory agencies during audits. * Mentoring internal manufacturing operations staff on audit solutions and training staff on compliance issues & regulations (HAACP, cGMP, 21 CFR Part 11). * Leading global compliance initiatives Desired Skills: * 3-5+ years of industry Quality & Compliance experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Food Safety, Nutrition, Pharmaceutics, Food Science, Biology or related life sciences field. MBA a plus. * Strong experience managing plant sanitation and hygiene compliance programs. * Expertise working with dairy spray dry, powder processing, milk powder, dairy powder, and low acid retort thermal processing processes. * Strong experience leading external audits internally and with 3rd party suppliers and contract manufacturing facilities. * Compliance expertise ensuring HAACP, cGMP and 21 CFR Part 11 compliance. * Experience working with the FDA & other regulatory agencies. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Grand Rapids, MI |
| Sr. R&D Thermal Process Specialist, Complex Food Manufacturing - Southern Indiana
This is a stellar opportunity within an established and growing Midwest based complex nutritional foods market leader. You will be responsible for serving as a subject matter expert for retort thermal processes for complex nutritional products. Your responsibilities will also include: * Serving as R&D Thermal Process team lead for process validations on projects. * Leading and supporting Retort and Aseptic Manufacturing processes for process design, process testing, and deviation analysis. * Developing and delivering strategic technical communication to key stakeholders, management, and team members with compelling technical recommendations and the business case for implementation. * Stimulating, developing, and optimizing processes to fully leverage varying manufacturing capabilities. * Identifying innovative concepts and technologies, perform rapid technical assessments, and incorporate into functional and commercially viable processes. * Conducting trials and retort heat penetration and distribution studies in pilot plant and manufacturing environments independently or under supervision of senior team members. * Using, maintaining, and ordering when necessary basic food lab instrumentation (i.e., pH meters, viscometers, weigh balances, water activity meters, data traces). * Developing, monitoring, and controlling budgets for projects and innovation efforts as applicable. * Assisting product development and pilot plant associates in experimental trials and equipment operation. * Comply with EHS and GMP practices and policies. * Resolving processing-related problems using hypothesis driven, structured problem solving. * Keeping organized thermal process records and laboratory notebooks in compliance with GMP/GLP standards. * Collecting and analyzing data to compose validation protocols and project reports. * Communicating technical information to R&D department and other cross-functional teams. Desired Skills: * Bachelor?s degree (B.S.) in Chemical or Food Process Engineering, or a related field with 3-5+ years of industry experience. * Experience with multiple food/diary unit operations, specifically retort and aseptic liquid processes. * Strong technical leadership skills and experience in process research and development experience. * Tenacity for scientific problem-solving and stringent criteria for accountability in decision making. * Excellent innovation and analytical skills, and commitment to seek feedback and build alignment with key stakeholders. * Strong history of leading by influence and delivering results with excellence. * Ability to work well in a fast-packed, multi-task environment with a high degree of teamwork, flexibility, and collaboration. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Evansville, IN |
| Utilities Planner/Scheduler, Complex Foods Manufacturing
This is a unique opportunity responsible for facilitating and communicating planned maintenance activities for facilities and utilities supporting the manufacturing of Food and Nutritional products. You will also be responsible for: * Developing and implementing preventative, corrective, and shutdown related job plans for all utilities systems including Refrigeration, Compressed Air, Steam Generation, Process Water, and Electrical distribution systems. * Develops equipment lists, design criteria codes, enters new equipment into computer information system, to better utilize the information into CMMS system. * Utilizing CMMS SAP Maintenance System CMMS for the purpose of tracking equipment history, labor & material spending, and all maintenance activities related to the facility and production equipment. * Facilitates and communicates planned maintenance activities with production / crafts from shift to shift * Coordinates the planning and scheduling of external contractor work to support Manufacturing * Manage outages and maintenance projects, long term maintenance planning for future outages, including corrective maintenance work * Provides technical assistance and/or resources to address maintenance issues as required * Completes timely follow-up of planned maintenance activities * Assist with the management of contracted maintenance expense budgets * Working knowledge of Maintenance CC/GL accounts and classifications * Knowledge of HACCP/GMP/FDA/MIOSHA safety standards Desired Skills: * Experience leading the scheduling and maintenance for utilities and equipment such as Refrigeration, Compressed Air, Steam Generation, Process Water, and Electrical distribution. * Experience leading the scheduling and maintenance for utilities such as WFI, electrical systems and compressed air. * Experience working with Computerized Maintenance Management Systems such as SAP CMMS. * Experience leading manufacturing site Operational Excellence and Lean Manufacturing programs. * Food & Beverage, Dairy Foods, Dairy Spray Dry or Nutritional Foods manufacturing expertise working within cGMP, FDA, HACCP & OSHA compliance. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Grand Rapids, MI |
| Process Engineer, Complex Foods Manufacturing
This is a stellar early career opportunity within an established, thriving, and growing Midwest based complex nutritional foods market leader. You will serve as a technical leader overseeing Process Improvements, Yield Improvements and Process Troubleshooting activities within a high volume and highly regulated complex food manufacturing environment. Your responsibilities will also include: * Leading Process Improvements, Yield Improvements and Process Troubleshooting activities for complex nutritional food manufacturing. * Assessing and implementing improvements for Plant CIP/COP/Master Sanitation. * Effectively communicating technical topics to key stakeholders, management, and team members to influence decisions. * Partnering with Operations, R&D, and Quality team members to ensure products are manufactured correctly from project conception to completion. * Using knowledge of unit operations and engineering principles to troubleshoot processing and equipment issues. * Developing and optimizing functional requirements for the plant floor control system. * Identifying and implementing cost reduction strategies. * Setting technical standards for operations, maintenance, safety, and quality. * Developing protocols to qualify processes and equipment (IQ, OQ, PQ) validation efforts. * Applying and understanding HACCP, GMPs, and regulatory requirements to process design and qualifications. * Incorporating understanding of corporate safety and environmental standards into execution of Product/Process trials and development of process sites. Desired Skills: * 1+ year of food, pharma or nutritional foods industry/co-op/internship experience. * B.S. or M.S. in chemical engineering, food science, food technology, or a related field a plus. * Knowledge and xperience in CIP, liquid milk processing, spray drying, blending, powder transport, and packaging a plus. * Knowledge of nutritional products, food chemistry, analytical sampling and testing, and product formulation strongly desired. * Familiar with process engineering, reaction kinetics and modeling, equipment design, thermodynamics, and process optimization. * Experience in technical writing, process and quality control documentation, and technical presentations. * Knowledgeable in Lean Manufacturing, Six Sigma, Continuous Improvement, Operational Excellence or statistical applications (DOE, ANOVA, capability analysis, etc.) desired. * Knowledge of regulatory FDA GMP requirements for food manufacturing desired. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Grand Rapids, MI |
| Maintenance Supervisor
This is a stellar opportunity within an established, thriving, and growing Midwest based complex nutritional foods market leader. You will be responsible for managing the maintenance of all equipment and machines for the manufacturing of all products in the plant. Your responsibilities will also include: * Developing best in class maintenance systems to assure a high level of support for the facility. * Identifying and integrating best practices such as Continuous Improvement, Predictive and Autonomous Maintenance. * Prioritizing activities, coordinating and scheduling maintenances, and providing leadership and direction to support manufacturing operations. * Providing support for maintaining accurate and current fixed asset inventory listing for the equipment while ensuring complete and accurate information is entered into the CMMS system. * Building technical competencies within the maintenance team. Identifying and selecting new maintenance team members that support developing technological needs. * Leads the maintenance team by providing a clear vision, defining specific and timely objectives, and using metric reporting to monitor team activities. * Managing the development and administration of operating expense and capital spending budgets for the maintenance department. * Driving a data driven Asset Health program to reduce downtime. * Conducting bench marking studies to determine best practices for the maintenance department. * Responsible for running the work schedule and payroll. Desired Skills: * Technical degree in electronics or engineering; 2-year degree acceptable, 4-year degree preferred. * 10+ years of maintenance experience and 3 years of maintenance supervisory experience with degree; 5+ years of maintenance supervisory experience without degree. * Demonstrates strong project management skills. * Strong knowledge in packaging. Knowledge of lyophilization procedures a plus. * Understanding of maintenance best practices, safety, quality, cost, HACCP, GMP, and FDA regulatory compliance. * Proven decision-making skills, strong troubleshooting, planning, prioritization, multi-tasking, and delegation skills. * Ability to communicate issues, goals, and objectives to facilitate an effective team-oriented environment. * Demonstrated ability to work with a range of technically and culturally diverse people, delivering value added business results that meet high quality * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Zeeland, MI |
| Automation Technician, Nutritional Foods Manufacturing
This is a stellar opportunity within an established, thriving and growing Midwest based complex nutritional foods market leader. You will be responsible for performing the maintenance, troubleshooting, and upgrades for the plant networks, automation, and instrumentation system. Your responsibilities will also include: * Knowledge of DeltaV DCS automation and controls systems.PLC programming, installation, and troubleshooting, preferably Allen Bradley controllers. * Project development, maintenance, and troubleshooting of industrial and computer networks including DeviceNet, Ethernet/IP, Ethernet TCP/IP, PROFIBUS, and/or BACnet * Performing process engineering and maintenance engineering activities working with process control equipment and systems including PLC, HMI, DeltaV and other MES systems. * Executing Automation Validation deliverables for SCRs and projects by utilization of Computer Systems Validation. * Ensuring compliance to FDA and OSHA regulations, writing SOPs, and developing PFD and P&ID, equipment and piping layout, and process and equipment specifications for bids. Desired Skills: * Associates or Bachelor?s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering or related Engineering field. * Food Processing, Nutritional Foods, Pharmaceutical or Regulated Consumer Products industry experience. * Expertise with process control and automation systems including Emerson DeltaV, Rockwell automation systems and building automation systems (including Metasys). * Experience with Allen-Bradley PLC platforms including PLC-5, SLC and Logix families of controllers, Allen-Bradley variable frequency drives and servo drives and Allen-Bradley PanelView human machine interfaces. * Knowledge of industrial computer and automation network/communication protocols including Ethernet TCP/IP, Ethernet/IP, DeviceNet, PROFIBUS and/or BACnet. * Excellent equipment troubleshooting and Computer Systems Validation (CSV) experience. * Expertise working within HACCP or cGMP compliance. About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Grand Rapids, MI |
| Maintenance Planner/Scheduler, Complex Foods Manufacturing
This is a unique opportunity responsible for facilitating and communicating planned maintenance activities for facilities and utilities supporting the manufacturing of Food and Nutritional products. You will also be responsible for: * Assist Maintenance Supervisors and Project Engineers in the planning of work requests and PM's to achieve timely completion goals. * Develops equipment lists, design criteria codes, enters new equipment into computer information system, to better utilize the information into CMMS system. * Utilizing CMMS SAP Maintenance System CMMS for the purpose of tracking equipment history, labor & material spending, and all maintenance activities related to the facility and production equipment. * Facilitates and communicates planned maintenance activities with production / crafts from shift to shift * Coordinates the planning and scheduling of external contractor work to support Manufacturing * Manage outages and maintenance projects, long term maintenance planning for future outages, including corrective maintenance work * Provides technical assistance and/or resources to address maintenance issues as required * Completes timely follow-up of planned maintenance activities * Assist with the management of contracted maintenance expense budgets * Working knowledge of Maintenance CC/GL accounts and classifications * Knowledge of HACCP/GMP/FDA/MIOSHA safety standards Desired Skills: * No degree required, 2-4 year technical degree a plus. * Experience leading the scheduling and maintenance for facilities and equipment such as clean rooms, tanks, blenders and conveyor systems. * Experience leading the scheduling and maintenance for utilities such as WFI, electrical systems and compressed air. * Experience working with Computerized Maintenance Management Systems such as SAP CMMS. * Experience leading manufacturing site Operational Excellence and Lean Manufacturing programs. * Food & Beverage, Dairy Foods, Dairy Spray Dry or Nutritional Foods manufacturing expertise working within cGMP, FDA, HACCP & OSHA compliance. About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Grand Rapids, MI |
| Sr. Reliability Engineer, Complex Foods Manufacturing
This is a unique opportunity responsible for leading and driving site wide Reliability Engineering initiatives for the manufacturing of complex food products. It's an outstanding opportunity responsible for championing Reliability Engineering, Reliability Strategies and Predictive Maintenance programs to harmonize site-wide manufacturing processes. You will also be responsible for: * Driving and implementing Reliability Engineering, Reliability Strategies and Predictive Maintenance programs site wide. * Utilizing key reliability tools including RCA, PdM and FMEA to champion cost reductions and manufacturing improvements. * Managing predictive technologies including Vibration Analysis, thermography, Infrared Analysis and Oil Analysis to increase equipment uptime. * Developing creative solutions to achieve the highest metrics for increasing equipment uptime availabilities, performance capacities, and OEE Overall Equipment Effectiveness. * Developing plans to implement global TPM (Total Productive Maintenance) pillars involving preventative maintenance, periodic maintenance, corrective maintenance, and maintenance prevention activities to achieve zero defects, zero breakdown, and zero accidents in all functional areas of the organization. * Utilizing continuous improvement, TPM, Total Quality Management, Six Sigma methodologies, and Lean Manufacturing techniques to develop a best in class maintenance program. * Supporting capital projects and process improvements involving high volume packaging systems and food production equipment including blending systems, mixing tanks, steam injectors, spray dryers, and liquid processing tanks. * Serving in a Project Leadership role managing complex, strategic cross-functional projects for delivering Reliability Excellence across a rapidly growing complex food manufacturing site. Desired Skills: * BS or MS degree in Mechanical Engineering, Electrical Engineering, Biochemical Engineering, Chemical Engineering or related Engineering field. * 5+ years of experience leading and championing Reliability Engineering or Maintenance Engineering related initiatives and programs. * Experience leading manufacturing site Operational Excellence and Lean Manufacturing programs. * Expertise developing, implementing and executing RCM principal and techniques including vibration analysis, infrared thermography, oil analysis, non-destructive testing, and material chemical compatibility. * Experience implementing strategic TPM Maintenance Systems, TPM Pillars, and Maintenance master plans. * Food & Beverage, Dairy Foods, Dairy Spray Dry or Nutritional Foods manufacturing expertise working within cGMP, FDA, HACCP & OSHA compliance. * Lean Six Sigma Green Belt, Black Belt or Master Black Belt Certification a plus. About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Grand Rapids, MI |
| VP, Head of Gene Therapies Technology Research and Development
An exciting executive-level leadership opportunity with an industry leading biosimilar company. You will be responsible for managing a team of scientists through strategy and execution of technology, research, and development. Your responsibilities will also include: * Leading and optimizing AAV vector and capsid engineering. * Leading research strategies for the development of target specific AAV vectors, capsid library and therapeutic target directed engineering, and producer cell line development. * Managing and directing a fully dedicated, highly motivated, and rapidly growing team of 15+ scientists capable of high productivity and delivery of top-quality data. * Conducting due diligence on external innovation opportunities. * Collaborating with cross-functional internal and external partners. * Communicating with and presenting as requested to executive level management. * Building and maintaining relationships with expert technical advisors. * Developing and mentoring junior team members. * Recruiting additional talent proportionate with organization growth. * Managing budget, including decisions as to when to re-allocate or request more funds. Desired Skills: * Ph.D. in Gene Therapy, Virology, Cell Biology, Molecular Biology, or related field. * 10+ years post graduate experience in the biotech/pharmaceutical industry. * Hands-on experience with AAV engineering and optimization, capsid library development and evolution, or producer cell line development as well as associated analytical methods is highly desired. * Experience with next-generation sequencing platforms if preferred. * Ability to provide clear rationalized decisions and communicate them to team members, executives, and top-most levels of management. * Experience managing and mentoring direct reports including PhD level scientists. * Ability to work collaboratively across dynamic and collective scientific environments. About the Company: This rapidly growing biosimilar company offers an extensive pipeline of opportunities through process innovation, providing the heath-care industry with innovative therapies for patients with neurodegenerative diseases, hemophilia and auto-immune disorder. |
Los Angeles, CA |
| National Account Director
This is a stellar opportunity within an established, thriving and growing biosimilar company. You will be responsible for building and maintaining strong long-term relationships with partners and clients. Your responsibilities will also include: * Delivering a US Market Access approach that is fully aligned with corporate objectives and finances. * Serving as a key point of contact with strategic partners and leading partner alliances. * Creating and maintaining an account and customer database by channel for assigned customers. * Identifying new market access opportunities to optimize access and reimbursement of products. * Developing and maintaining relationships with customers to ensure short-term and long-term success. * Developing and planning target account and strategic account plans for all channels. * Networking with key customer and commercial partners to identify and address specific business opportunities. * Identifying and attracting prospective strategic customers, negotiating contracts when appropriate. * Developing forecasts that accurately predict market share growth, sales revenue, and profitability of all contracts. * Supporting annual refresh of account profiling, segmentation, and targeting. * Collecting and analyzing sales data and trends. * Staying up to date with internal and external developments. Desired Skills: * Ph.D. or MBA in life sciences, economics, management, marketing, or finance preferred. * 10+ years working within the bio/pharmaceutical industry with at least 7 years of pharmaceutical marketing experience of prescription medications. * 5+ years of experience in market access, payer marketing, or key account management. * 3+ years of experience of leadership in a matrix environment with cross functional teams. * Experience working in a global organization and collaborating with regional teams and commercial partners. * Experience developing and managing a portfolio strategy for a pharmaceutical company. * Ability to manage cross functional groups to accomplish corporate goals. * Professional level English speaking, writing, and interpersonal skills are required. * Ability to understand, interpret, and present US demand and forecast data to support product strategies. * Ability to understand US healthcare system, policies, and attitudes toward biosimilars. * Knowledge of product valuation, P&L structure, and other relevant analytical data. About the Company: This rapidly growing biosimilar company offers an extensive pipeline of opportunities through process innovation, providing the heath-care industry with innovative therapies for patients with neurodegenerative diseases, hemophilia and auto-immune disorder. |
Los Angeles, CA |
| SBUS PBM/Strategy/Payer Engagement (Director to VP)
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About the Company: This rapidly growing biosimilar company offers an extensive pipeline of opportunities through process innovation, providing the heath-care industry with innovative therapies for patients with neurodegenerative diseases, hemophilia and auto-immune disorder. |
Gaithersburg, MD |
| Drug Product Senior Scientist
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Scientist, C&G Therapy
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
New York, NY |
| Sr. Manager/Associate Director, Drug Substance Quality
This is a stellar opportunity leading quality oversight for new modalities including mRNA, Viral Vector and Cell & Gene Therapy Operations. This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. You will be charged with overseeing the following activities: * Overseeing and supporting Quality system setup of new modalities such as mRNA, Viral Vector and Cell & Gene Therapy (CG&T) operations. * Serving as a Quality Project Management lead for quality oversight on tech transfer and product lifecycle management activities and author regulatory documents for mRNA products. * Reviewing and approving validation and performance qualification protocols and reports, including investigations. * Leading and generating Quality Management Systems metrics for quality improvement efforts. * Authoring CTD sections relevant to GMP processes and APQR documents. * Maintaining up to date knowledge of statutes, regulations, guidelines and guidance to make regulatory decisions. * Leading oversight of DS operational issues and shop-floor maintenance for DS area to ensure that the process conforms to the established standards. * Maintaining GMP standards and requirements through review and approval of GMP documents (MBR/SOP) Desired Skills: * 6+ years Biopharmaceutical or Biotechnology industry experience. * BS in Chemistry, Biotechnology, Microbiology, Biology, related life sciences or engineering field. * Quality Systems Expertise implementing and managing Quality Management Systems (QMS) with ability to clearly communicate GMP/Quality topics with clients. * Quality Systems experience overseeing Deviations, CAPA, Change Control and GMP Document Management capabilities. * Experience in mRNA, Viral Vector and Cell & Gene Therapy (CG&T) drug substance/product manufacturing processes. * Experience ensuring cGMP compliance and knowledge of FDA, ICH and EU regulations. * thirty About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| DP Compliance, Technical Support
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
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| Validation Manager Visual Inspection, Drug Product Manufacturing - Expatriate Opportunity In South Korea
This is an exciting foreign expatriate leadership opportunity responsible for participating in validation of visual inspection for related drug product and fill/finish manufacturing activities for large scale clinical and commercial recombinant protein manufacturing. This is a unique opportunity within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation. You will be charged with overseeing the following activities:
1. Subject matter expert in Automatic Inspection Machines 2. Establish Visual Inspection Processes 3. Senior Manual Inspector 4. Assist in leadership & management of Manual Inspectors Key Responsibilities 1. Serves as a key site technical SME for automated visual inspection technologies, Manual inspection, secondary packaging (including serialization). 2. Provide guidance, leadership and manage own time to meet objectives and plan resource requirements for projects. 3. Identify and implement cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity. 4. Incorporate Current Good Manufacturing Practices regulatory and safety compliance into all assigned projects' scope and design. 5. Investigates deviations of high complexity, involving multiple departments, with significant scope that occur on the manufacturing floor. Performs root-cause analysis, and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups. 6. Authors and performs documentation, including SOPs, MBRs, Protocols and Reports. 7. Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization, and investigates common cause process variation. 8. Responsible for training operations colleagues on aspects of processes, inspection and equipment operation. 9. Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity. 10. Develops and validates manufacturing processes for drug products, taking into consideration problems in the technical transfer to production. 11. Responsible for audit preparation, documentation, follow up for Inspection and Packaging within the DP BU. Present investigations, procedures or practices to auditors, and acts as an SME for tours. 12. Contributes SME knowledge on emerging technologies and develops and shares best practices. 13. Responsible for technical development of junior colleagues *THIRTY Desired Skills: * Associates or Bachelors degree in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience in Visual Inspection field of sterile drug product manufacturing processes. (Vial, PFS) * Experience with Manual, Semi-auto & Automatic visual inspection process * Experience in validation of manufacturing drug product processes * Broad understanding of regulatory and quality requirements for Drug products * Broad understanding of Aseptic drug product process, filling procedures, freeze drying, packaging etc. * Knowledge of Drug product Visual inspection and Packaging process including validation regulation About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
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| Quality Management System Senior/Principal Specialist
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Sr Scientist/Principal Scientist, mRNA Development - Expat in Korea
This is an exciting new Expat opportunity responsible for leading mRNA Development activities within a newly expanded Advanced Research Lab Business Unit. This is a once-in-a-lifetime Expat leadership opportunity within the World's Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. You will be charged with overseeing the following activities: * Leading new R&D projects focusing on the development of novel RNA based therapeutics and mRNA vaccines within a newly expanded Advanced Research Lab Business Unit. * Developing RNA technologies pertaining to novel therapeutics and the understanding of biological consequences of synthetic modified RNA. * Optimizing RNA sequences and structure for enhanced modularity and function. * Leading and performing molecular biology techniques including DNA cloning, RT-PCR and nucleic acid purification. * Leading and performing molecular biology laboratory techniques including nucleic acid amplification, in vitro transcription, primer/probe/vector design, PCR, NGS and molecular cloning. * Leading and performing assay development and validation of ELISA, HPLC, Cell-Based Assays and Bioassays. * Performing data analysis including library construction approaches, RNA-seq, Ribo-seq, eCLIP, scRNA-seq, Nanopore and running computational pipelines for sequencing analysis. * Collaborating cross functionally with process development and manufacturing teams. Desired Skills: * Ph.D. in Molecular Biology, Cell Biology, Biochemistry, Biophysics, Biochemistry, Biology, Chemistry or related Life Sciences field. * 3-5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific expertise leading and performing molecular biology techniques including DNA cloning, RT-PCR and nucleic acid purification. * Expertise performing assay development and validation of ELISA, HPLC, cell-based assays, immunogenicity assays and bioassays. * Scientific expertise working with mRNA development or mRNA vaccine transcription a plus. * Drug Development and Commercialization contributing to IND, NDA, BLA and CMC regulatory filings a plus. * thirty About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Scientist/Senior Scientist (Molecular Biology)
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Director, Drug Product Manufacturing MSAT - Expatriate Opportunity In South Korea
This is a stellar opportunity responsible for leading a broad set of technical oversight of large scale Drug Product Fill/Finish capabilities. This is a once-in-a-lifetime expatriate leadership opportunity. Your roles and responsibility will include: Tech Transfer - Perform a wide variety of tasks and operations that are required to support the Technical Transfer and manufacturing of Drug Products - Create, revise and manage technical documents (protocols, reports, Process Control Strategy, Failure Mode Effects Analysis, etc.) - Support troubleshooting and general technical support (documentation reviews, deviation investigations, product impact assessment, etc.) - Technical input for drug product CMC sections of regulatory filings - Support PAI and PAI readiness Life Cycle management - Support all technical aspects of commercial drug product manufacturing, including implementation of process improvements, trouble shooting, and technical investigations - Recommend process improvement projects to internal and/or external partners and follow up on its implementation Project Management - Ensure following MSA and PSA condition, payment planning and tracking - Master Project Schedule Development to monitor and track progress, Scope of Work developMaster Project Schedule Development to monitor and track progress, Scope of Work develop - Regular (weekly/monthly) Client communication management of forecast/manufacturing tion management of forecast/manufacturing schedule, change controls, deviations, risks and mitigationsschedule, change controls, deviations, risks and mitigations - Financial Management of PO and Invoice schedule (batch cost +) - Project Change Request management - Management of Core team/JSC agendas, meetings, and minutes - Management of cross functional/client communication for critical issues - Monitor subteam process and facilitate communication with client - Main point of contact for clients regarding all items - Effectively manages relationship with client and all pertinent stakeholders - Creates and maintains comprehensive project documentation - Campaign readiness management - Create and manage commercial batch tracker Desired Skills: * 15+ years Biopharmaceutical or Biotechnology industry experience. * BS, MS or Ph.D. in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Leadership experience working on Drug Product fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics. * Technical expertise and knowledge involving aseptic processing, lyophilization and related fill/finish Drug Product technologies. * Technical leadership experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. *THIRTY About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Sr. Manager/Director, Commercial Process Verification MSAT
This is an exciting foreign expatriate leadership opportunity responsible for managing Commercial Process Verification (CPV) MSAT operations for large-scale commercial recombinant protein manufacturing. This position is immediately available due to major company and plant expansions with the addition of a new 256,000 Super Plant 4 operational in 2022. It?s also a unique growth opportunity within the world?s largest Global Contract Manufacturing Organization (CMO) working with major Global BioPharma companies. You will be charged with overseeing the following activities: * Managing Commercial Process Verification (CPV) for commercial biologic products during manufacturing. * Leading MSAT team members for upstream cell culture and downstream purification Drug Substance manufacturing operations. * Overseeing Process Cycle Management activities including the management of commercial documents after PAIs, writing Continued Process Verification (CPV) reports and APQR. * Leading commercial process improvements including process monitoring to ensure a robust commercial supply. * Managing customer/client interactions including production monitoring, technical communications and deviation resolution. * Providing technical leadership and subject matter expertise relating to downstream related manufacturing deviations, change controls, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead process improvement, process validation, process change control, deviation investigation, CAPAs and process characterization activities. * Serving as a technical/scientific SME for downstream protein purification activities ranging from column chromatography, filtration (UF, DF, TFF), harvest and recovery. * Serving as a technical/scientific SME for upstream cell culture activities ranging from vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations. * Assisting in the build-out of BioPharma Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems. * Contributing to CMC preparation and filings and FDA Regulatory Inspections. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Expertise managing Commercial Process Verification (CPV), Process Cycle Management, Continuous Process Verification and Process Monitoring activities for the manufacturing or large-scale commercial biologic products. * Scientific and technical experience performing downstream purification manufacturing activities including column chromatography, filtration (UF, DF, TFF) and recovery for the manufacturing of recombinant protein and monoclonal antibodies. * Scientific and technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations for the manufacturing of recombinant proteins, monoclonal antibodies or mRNA vaccines. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma methodologies. About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Process Innovation Expert
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Sr. Manager, Facility Quality, Biologics Manufacturing
This is a stellar opportunity leading a broad set of Facility Quality Operations for large scale commercial biologics bulk manufacturing and fill/finish capabilities. This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. You will be charged with overseeing the following activities: * Leading overall inspection readiness including regulatory inspections, client audits and due diligence. * Leading GMP document review and approval for change control, CAPA, deviations, SOPs and other GMP documents. * Generating and executing validation protocols for facility and utilities validation activities including HVAC, WFI and Clean Steam. * Providing Quality recommendations for facility maintenance and utilities operations. * Leading Quality Assurance oversight of product release, batch record execution, batch record review, approval of production deviations, change controls, compliance, and investigations. * Leading Quality Engineering operations including Validation, Technical Operations, Technical Troubleshooting, and CAPA. * Overseeing Quality Risk Management activities. * Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance. * Hosting regulatory inspections, leading inspection readiness activities, and leading Pre-Approval Inspections (PAI) and serving as a facility tour escort during regulatory inspections, audits and virtual audits. * Working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA. Desired Skills: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS, MS or Ph.D. in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biology, Chemistry or related Engineering or life sciences related field. MBA a plus. * Experience hosting and leading global regulatory audits and regulatory inspections. * Quality Operations leadership facilities, utilities (HVAC, WFI and Clean Steam) or plant maintenance related operations. * Quality leadership experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Experience working in a Facility Operations, Facility Maintenance or Facility Quality Operations position. * Strong experience ensuring cGMP compliance and working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA. * thirty About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
San Francisco, CA |
| Director Drug Product Quality, BioPharma Manufacturing - Expatriate Opportunity In South Korea
This is a stellar opportunity responsible for leading a broad set of technical oversight of large scale Drug Product Fill/Finish capabilities. This is a once-in-a-lifetime expatriate leadership opportunity within the World?s Largest biologics CMO with over 362,000L mammalian cell culture manufacturing capacity. Your roles and responsibility will include: * Leading Drug Product Quality team members. * Providing Quality oversight of Drug Product tech transfers, investigations, technical studies and process improvement projects. * Providing decision support for Quality issues related to Drug Product manufacturing, testing and release. * Supporting clients with regards to incoming tech transfers and remediation of product complaints and investigations. * Reviewing and approving Drug Product Quality Risk Assessments. * Identifying Drug Product related compliance risks and guiding remediation efforts. * Providing training and mentorship to develop internal employees. * Leading a cGMP Quality Compliance team overseeing Internal Audits, External Audits, Customer Inspections and Regulatory Inspection activities. * Owning and overseeing Quality Compliance, Risk Mitigation and Risk Management activities including Compliance Risk Assessment as well as Process Compliance Risk Registry, Remediation and Tracking. * Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance. * Hosting regulatory inspections, leading inspection readiness activities, and leading Pre-Approval Inspections (PAI). * Working directly with global regulatory agencies including the FDA, EMA, MHRA, Health Canada, PMDA, and KFDA. Desired Skills: * 15+ years Biopharmaceutical or Biotechnology industry experience. * BS, MS or Ph.D. in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality leadership experience working on Drug Product fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics. * Technical expertise and knowledge involving aseptic processing, lyophilization and related fill/finish Drug Product technologies. * Quality leadership overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities capacities. * Quality leadership experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Experience hosting and leading global regulatory audits and regulatory inspections. * Strong experience ensuring cGMP compliance and working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA. *THIRTY About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
San Francisco, CA |
| Sr. Manager/Associate Director Veeva Quality Systems
This is a stellar opportunity leading a broad set of Quality Management Systems including Veeva QMS for large scale commercial biologics bulk manufacturing and fill/finish capabilities. This is a once-in-a-lifetime expatriate position responsible for overseeing Quality operations within the World?s Largest biologics CMO with 362,000L mammalian cell culture manufacturing capacity. Your roles and responsibility will include: * Serving as a Quality Project Management lead for Quality Management Systems including enterprise Veeva QualityDocs, Veeva Vault QMS and Waters Empower LIMS. * Managing sitewide Quality Management Systems teams including Deviations, CAPA, Change Control and GMP Document Management groups across 3 manufacturing plants. * Leading Quality Assurance oversight of product release, batch record execution, batch record review, approval of production deviations, change controls, compliance, Quality Risk Management and investigations. * Leading Quality Assurance oversight of Upstream Cell Culture manufacturing, Downstream Purification Manufacturing, Drug Product/Aseptic Fill, Validation, Computer Systems Validation and Quality Control labs. * Leading Quality Systems Management including the Quality Compliance, in-house compliance systems, and document control systems. * Serving as a QA Lead for Data Integrity, Design Review, Access Control, Operational Verification and Performance Verification Testing. * Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance. * Working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA. Desired Skills: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS, MS or Ph.D. in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Systems Expertise implementing and managing Quality Management Systems (QMS) including enterprise Veeva QualityDocs, Veeva Vault QMS and Waters Empower LIMS. * Quality Systems experience overseeing Deviations, CAPA, Change Control and GMP Document Management capabilities. * Quality leadership experience working within bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics or fill/finish operations for biologics, pre-filled syringe, or protein lyophilized therapeutic manufacturing environments. * Expertise in Data Integrity, Design Review, Access Control, Operational Verification and Performance Verification Testing. * Strong experience ensuring cGMP compliance and working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA. About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Contract Manager
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Los Angeles, CA |
| Regulatory Affairs (SF or Korea)
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About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Glendora, CA |
| Viral Clearance Project Manager
This is an exciting foreign expatriate leadership opportunity responsible for setting up a new BioSafety Viral Clearance testing service operation. This is also a unique opportunity serving as a key team member within a new fast growing CRO organization which is part of the World?s Largest biologics Contract Manufacturing Organization (CMO) with 362,000L total mammalian cell culture manufacturing capacity. You will be charged with overseeing the following activities: * Developing and building up the new BioSafety Viral Clearance functional unit within a new fast growing CRO organization. * Serving as the Virus Production specialist for both upstream cell culture and downstream purification processes. * Serving as the Virus Production SME for understanding charactistics of viruses including MVM and X-MuLV * Preparing reagents and materials required for virus production. * Leading virus purification by TFF, centrifugation and AKTA chromatography. * Training team members in Virus Production processes and techniques. * Analyzing virus titers and purity. * Managing 2-3 team members including Scientists performing Viral Clearance Studies. * Serving as the primary point of contact with clients regarding Viral Clearance technical support. * Training team members in Viral Clearance processes and techniques including Viral Clearance Studies, Sample Generation and Plaque Assays. * Developing methods and training team members for qPCR detection of X-MuLV for Viral Clearance Studies. * Developing processes for viral removal, viral filtration, column chromatography and virus inactivation. * Ensuring laboratory methods and testing procedures are conducted within GLP and GDP compliance. * Serving as GLP Study Director * Preparing and filing GLP documents required for Viral Clearance Studies. Desired Skills: * BS or MS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Expertise working with virology-based assays including plaque assays and TCID50 assays. * Experience in qPCR detection of X-MuLV for Viral Clearance Studies. * Experience in viral removal, viral filtration, column chromatography, AKTA instrumentation and virus inactivation. * Working knowledge of GLP, GDP, FDA and EMA laboratory compliance. About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Malvern, PA |
| Site QC Microbiologist, BioPharma Manufacturing - Expatriate Opportunity In South Korea
This is an exciting US expatriate opportunity responsible for overseeing all Site Quality Control Microbiology activities within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation. You will be charged with overseeing the following activities: * Overseeing Site Quality Control Microbiology Operations within a multi-plant large scale mammalian cell culture manufacturing environment with 180KL to 360KL commercial manufacturing capacity. * Overseeing advanced microbiology testing including sterility, bioburden, endotoxin and microbial identification. * Leading QC Microbiology related Manufacturing Science and technical troubleshooting activities including deviation handling and investigations. * Overseeing contamination control programs such as aseptic processing, environmental monitoring, gowning qualification practices, cleaning, sanitization, disinfection, sterility testing, bioburden testing and the identification of potential microbial contamination. * Leading microbial analytical method validation activities. * Overseeing the setup of new QC Microbiology laboratories and performing equipment qualification and validation. * Ensuring Microbiology related Pre-Approval Inspection (PAI) readiness and the hosting of FDA & EMEA audits and inspections. Desired Skills: * MS or Ph.D. in Microbiology. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Hands-on expertise leading QC microbiology testing and assays including sterility, bioburden, endotoxin and microbial identification. * Manufacturing Science/MSAT expertise leading microbiology related investigations with successful experience resolving related deviations. * Experience ensuring PAI readiness and hosting FDA/EMEA audits & inspections. * Strong Scientific expertise working within Quality Control laboratories testing for the generation of monoclonal antibody and recombinant protein therapeutic products. * Expertise leading microbiology related methods development, methods qualification, and methods validation activities. * Expertise working within cGMP compliance and providing GMP documentation. * twenty About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
Frederick, MD |
| Sr. Director Supply Chain, Biopharma Manufacturing - Expatriate Opportunity In South Korea
This is an exciting US expatriate position responsible for leading procurement activities within an emerging Biopharmaceutical Organization backed by a major multinational corporation. They have aggressively entered the Biopharmaceutical industry and are engaged in commercial contract manufacturing. You will be charged with overseeing the following activities:
* Provide expertise in routine planning and raw material incident management * Participate in the decision of supply chain procedure improvements * Establish manufacturing production plans, handle raw material imports and establish logistical improvements. *Deal with issues related to supply & material quality issues * Monitor inventory flow. * Communicate, educate and provide necessary information to supply chain stake holders throughout the chain to achieve clarity in supply needs Desired Skills: *B.S/M.S Business, Logistics, Supply Chain, or related discipline *Pharmaceutical/Biotech experience a must *18+ years of experience in Supply Chain/Logistics *Experience in logistics specifically international supply chain *Experience in Business Objects, SAP and global planning tools *SAP/ERP system experience a plus *THIRTY About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
San Francisco, CA |
| Project Manager, BioPharma CMO Manufacturing - Expatriate Opportunity In South Korea
This is an exciting US expatriate project leadership position responsible for overseeing all drug substance development from upstream mammalian cell culture development, downstream purification development, manufacturing activities and quality systems management. This is a unique opportunity within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation. You will be charged with overseeing the following activities: * Serving as the liaison between Clients to manage new orders and production campaigns * Plan, execute, and finalize projects according to strict deadlines, milestones and within budget. * Providing team leadership on projects of all mammalian cell culture process development, downstream purification development, and analytical methods development/characterization for the generation and manufacturing of monoclonal antibody and recombinant protein therapeutic products. * Scheduling projects with QA and QC, to ensure that all processes and productions comply with regulatory guidelines as well as ensuring controlled environments are maintained for the manufacture of high-quality products. * Leading project management of complex tech transfers between client sites and manufacturing facilities. Desired Skills: *BS, or MS in Chemistry, Biochemistry, Biology, Chemical Engineering or related Life Sciences field. * 10+ years of Project Management experience as it relates to BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong background leading and managing projects for large CMOs * Expertise leading projects on upstream mammalian cell based cGMP biologics manufacturing, downstream purification, analytical methods technology transfer, and process validation activities. * Experience ensuring quality assurance, quality control and experience working within cGMP compliance and providing GMP documentation. *THIRTY About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
San Francisco, CA |
| Vice President, Quality Control, BioPharma Manufacturing
This is an exciting US expatriate executive leadership position responsible for overseeing all Quality Control operations within a best in class Global Contract Manufacturing Organization (CMO). This position is responsible for overseeing all Quality Control operations within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture Drug Substance manufacturing capacity, mRNA vaccine manufacturing as well as major Drug Product manufacturing operations. Your roles and responsibility will include: * Overseeing Quality Control Operations within a multi-plant large scale mammalian cell culture manufacturing environment across 4 Manufacturing Plants with 362,000L to 620,000L commercial drug substance manufacturing capacity. * Overseeing and functional QC leadership teams and 500 person staff responsible for QC Microbiology, Environmental Monitoring, Raw Material Testing, in-process, lot release, stability and microbiology testing of therapeutic bulk drug substance and final drug products. * Leading teams responsible for QC Stability and Reference Standards Management activities. * Driving the strategic direction and QC Department roadmap and strategies in support of the company?s Quality vision. * Leading Quality Control Audits and Inspection Management capabilities including Client audit and inspections. * Driving QC Innovation Management to ensure resources are at all-time availability to support QC processes. * Leading projects for setting up new QC laboratories including new equipment qualification and validation. * Leading analytical methods qualification, methods validation activities and incoming tech transfer activities from external clients. * Leading QC related technical troubleshooting including deviation handling and investigations. * Supporting Business Development efforts for attracting new clients and projects. * Ensuring Lab Safety, Pre-Approval Inspection/PAI readiness and hosting FDA & EMEA audits & inspections. Desired Skills: * BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific/Engineering field. * 15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience from within a large scale or commercial biologics manufacturing environment. * Exceptional strategic team and functional QC organizational leadership * Strong Scientific and Engineering expertise leading Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Experience leading QC Stability, Reference Standards Management, and QC Stability testing and QC Stability studies. * Expertise leading QC methods development, methods qualification, and methods validation activities. * Experience overseeing QC Audits, QC Inspections, ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA/EMEA audits & inspections. * thirty About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
San Francisco, CA |
| Manager Biologics CDMO Sales/Business Development - Expatriate Opportunity In South Korea
This is an exciting US expatriate position within an emerging Global
Contract Manufacturing Organization (CMO) backed by a major
multinational corporation. The position is accountable for the execution of business development strategy to support the production of mammalian cell culture products. You will be charged with overseeing the
following activities:
*Assist in developing business development strategy *Accountability for identification of sales prospects, development of customer relationships and close of sales opportunities *Identifies business process improvement opportunities *Represent the company at conferences and trade shows *Ensure existing accounts are serviced effectively, obtain orders, and establish new accounts through organization and planning; implementing a tactical market plan Desired Skills: *B.S/M.S/Ph.D in Chemical Engineering, or related Life Sciences *MBA preferred *6-8 years of experience in Sales/Marketing/Business Development related to biologics contract manufacturing *Proven track record of sourcing and closing complex business partnerships *Strong written and verbal communication skills *THIRTY About the Company: This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. |
San Francisco, CA |
| Senior Engineer, BioProcess Systems Design
This is an exciting new opportunity to champion capital projects, innovation and improvements for the advancement of single use bioreactor products and engineering solutions. This position is within a growing and collaborative center of innovation for BioProcessing. It's also a unique high exposure opportunity offering career growth through contributing to industry publications, conference presentations and internal collaborations. Your overall responsibilities will also include: * Leading engineering solutions for the development and improvement of upstream mammalian cell culture equipment such as bioreactors and single use technologies as well as upstream cell culture processes supporting the manufacturing of recombinant proteins and monoclonal antibodies. * Ensuring engineering solutions align with Operational needs to maximize single use manufacturing rates. * Facilitating tech transfers within Operations utilizing modularized single use strategies. * Identify, define, and deliver additional value add opportunities to target manufacturing innovation, sustainability, and tech transfer efficiencies. * Provide technical support for upstream and downstream innovation projects within the development laboratory. * Assist with the roll out of augmented reality training tools to enhance manufacturing and design accuracy. * Establishing and capturing business critical metrics to support industry publications, case studies, and presentations. Desired Skills: * BS in Engineering, Biotechnology, Chemical Engineering with 4+ years of industry experience, or a combination of education and relevant work experience. * Strong Scientific and Engineering technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, and stainless-steel bioreactor operations. * Experience working within or functionally supporting cGMP operations and deviation investigations. * Direct experience working on mammalian cell culture processes utilizing various adherent cells and suspension cells such as Vero, HEK293, CHO cells. * Experience with Process Optimization, Six Sigma, or Process Improvement Methodologies. * Excellent written and oral presentation skills. * Ability to work with diverse collaborators and stakeholders in geographically diverse locations. About the Company: This is an exciting opportunity with a leading company offering full mammalian cell process development and the ideal candidate will responsible for driving implementation of Upstream based collaboration projects as a member of the Bioprocessing Collaboration Team. |
Saint Louis, MO |
| Associate Director/Director, Bioassay
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About the Company: This position is with an established and growing Bay Area BioPharma company developing and commercializing novel biologics and vaccines. |
South San Francisco, CA |
| Associate Director/Director, Analytical Development
This is an exciting Scientific Project Leadership opportunity responsible for overseeing the development, qualification, validation and technology transfer of analytical methods from early stage biologics development through to commercialization. You will also be charged with overseeing technology transfer activities of analytical development and testing activities with CDMO partners. You will also be charged with overseeing the following activities:
* Driving the technical oversight and development, qualification, validation and transfer of chromatographic, electrophoretic, and immunological methods targeted for in-process, release, and stability testing of early and late stage monoclonal antibody & protein therapeutic development programs. * Leading analytical methods qualification, methods validation activities and tech transfer activities with external contract manufacturers and CDMOs. * Preparing and reviewing documents in support of CMC regulatory submissions and writing responses to health authority questions. * Driving and leading stability studies, data trending, detection and reporting of trends and investigations in response to unusual or unexpected deviations. * Leading root cause analysis and unexpected results (OOS/OOT) investigation procedures and training staff members on best practices. * Partnering and interfacing with CMC operations and Quality Assurance team members to influence product characterization, QC testing, and regulatory strategies. * Providing expertise and technical leadership for troubleshooting product quality deviations impacting non-conformance and out of specification investigations. Desired Skills: Minimum Requirements: * MS, or Ph.D. in Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Life Sciences field. * 6+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience preparing, writing and contributing to CMC regulatory filings. * Experience partnering and working with External CMOs for analytical tech transfer activities. * Experience leading QC stability, degradation and comparability studies. * Expertise in DOE, QbD (Quality by Design), data analysis and statistical modeling. * Knowledge and expertise in analytical testing, analytical methods development, and characterization including HPLC, UPLC, Capillary Electropheresis, SEC, CEX, RP, HIC and other modern protein separation techniques. * Strong understanding of drug development processes and related GMP global regulations. * thirty About the Company: This position is with an established and growing Bay Area BioPharma company developing and commercializing novel biologics and vaccines. |
South San Francisco, CA |
| Director/Sr. Director MSAT
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About the Company: This position is with an established and growing Bay Area BioPharma company developing and commercializing novel biologics and vaccines. |
South San Francisco, CA |
| Sr MSAT Engineer, BioPharma Manufacturing
This is an exciting new opportunity responsible for leading Drug Product Manufacturing Sciences & Technology (MSAT) related activities for large scale clinical and commercial recombinant protein manufacturing. This is an exciting new opportunity to work onsite as a PIP at US Biologics Contract Manufacturing Organizations. Your roles and responsibility will include: * Serving as PIP at US Contract Manufacturing Organization sites. * Providing technical leadership and subject matter expertise relating to drug product fill & finish related deviations, change control, process optimization, and technical troubleshooting. * Handling of complex tech transfers for highly automated systems and overseeing all state-of-the-art equipment including formulation, aseptic liquid filling, pre-filled syringe lyophilization, and packaging apparatus. * Serving as a technical/scientific Subject Matter Expert drug product fill & finish activities. * Training engineering staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings. Desired Skills: * BS or MS in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments. * Strong Scientific and Engineering technical experience performing either upstream cell culture or downstream purification manufacturing activities * Upstream or Downstream expertise involving any of the following activities: vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations, column chromatography, filtration (UF, DF, TFF), harvest and recovery for the manufacturing of recombinant protein and monoclonal antibodies. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma. About the Company: This position is with an established and growing Bay Area BioPharma company developing and commercializing novel biologics and vaccines. |
Chicago, IL |