Company Job Listings

Job Title	Location
Sr. DeltaV Automation Engineer, BioPharma Manufacturing This is an exciting opportunity responsible for performing a broad set of automation & controls systems engineering activities within a major Maryland based state-of-the-art large scale commercial biologics manufacturing facility. You will be charged with overseeing the following activities: * Developing and implementing Emerson DeltaV related automation and controls systems projects within a large scale commercial manufacturing plant. * Performing process engineering and maintenance engineering activities working with process control equipment and systems including PLC, HMI, DeltaV and other MES systems. * Implementing and performing automation and control systems engineering activities involving large scale upstream mammalian cell culture, downstream protein purification, and BioPharmaceutical Manufacturing processes. * Creating S88 batch recipes and S88 standards. * Interfacing and integrating with MES and ERP Systems through ISA-95 & S95 Standards. * Providing outstanding equipment troubleshooting activities. Desired Skills: * BS degree in Biochemical Engineering, Chemical Engineering, Electrical Engineering, Mechanical Engineering or related Engineering field. * 3-5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Expertise with process control and automation systems including the Emerson DeltaV automation systems. * Expertise creating S88 batch recipes and S88 standards. * Experience programming DeltaV, PLC and HMI systems. * Excellent equipment validation, facility validation and IQ/OQ/PQ experience. * Expertise understanding engineering documentation including P&IDs and SOPs. * Expertise working with MES systems including Werum PAS-X or Emerson Syncade a plus. * Expertise working within cGMP compliance and providing exceptional GMP documentation. * thirty About the Company: The position is within a top Big Pharma company that is rapidly growing its development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of oral dosage small molecule and monoclonal antibody/ recombinant protein therapeutic products. A comprehensive benefits package is offered with this position.	Frederick, MD
Senior PLC Programming Automation Engineer, Pharma Manufacturing This is an exciting opportunity to provide technical project delivery of Automation and MES systems for the manufacturing of commercial pharmaceutical products. You will also be integral in the development and maintenance of key PLC and HMI systems including Rockwell Automation FactoryTalk View and OSI Pi Data Historian. Your roles and responsibility will include: * Providing technical project delivery across a portfolio of Automation and MES systems including Rockwell Automation, Wonderware systems and OSI Pi Data Historian. * Developing and maintaining HMI systems including Rockwell Automation FactoryTalk View. * Providing software lifecycle and change management, design specifications, programming of PLC and SCADA applications, configuring thin client server applications, configuring process-based historian databases, providing control system startup and commissioning services, troubleshooting existing control systems and providing control system qualifications. * Serving as domain specialist for automation systems during internal audits and regulatory inspections. * Performing periodic maintenance, testing, backups, security reviews and updates of applicable SOP?s related to Automation and MES systems and support the Facilities group by leading site wide building automation and utility control systems. * Partnering with Process Execution Teams to prioritize and implement modifications and upgrades to improve quality and operational efficiency of existing systems. * Leading project activities including interactions with equipment vendors, system integrators, and contracted personnel to implement projects involving Automation, Facilities, and MES systems to meet quality and technical standards. Desired Skills: * 5+ years of industry experience in Automation Engineering or Controls Systems Engineering. * BS or MS or Ph.D. in Electrical Engineering, Computer Science, Computer Engineering or related Engineering field. * Technical Experience working with Rockwell Automation products and/or Wonderware SCADA, Building Automation Systems (Delta V, Honeywell, Metasys) and Serialization systems. * Technical Experience working with FactoryTalk View or related HMI Software. * Technical Expertise developing and maintaining Programmable Logic Controller (PLC) systems. * Experience in HMI and PLC programming as well as modifying Rockwell Automation PLC and SCADA programs. * Knowledge of OSI Pi Data Historian. * Experience working within the Pharmaceutical, Biotechnology, Food Production, Medical Device or any other GMP or FDA regulated industry preferred. * Please note, this position is based in the Midwest but not in Louisville, St. Louis, Indianapolis or Nashville. A full relocation package is provided for this position. * About the Company: The position is within a top Big Pharma company that is rapidly growing its development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of oral dosage small molecule and monoclonal antibody/ recombinant protein therapeutic products. A comprehensive benefits package is offered with this position.	Evansville, IN
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. * thirty About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	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. * thirty About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Mc Farland, WI
Manager Downstream Purification, BioPharma Manufacturing You will be directly responsible for leading cGMP downstream protein purification commercial manufacturing activities ranging from harvest, filtration, chromatography, viral clearance and recovery. You will be responsible for 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. You will also be a key team member managing commercial Pre-Approval Inspections (PAIs) and interacting with Global regulatory agencies. Other responsibilities include implementing lean manufacturing techniques, process improvements, and electronic batch record systems. 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. 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: 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 Managing a staff of Manufacturing Supervisors, Manufacturing Associates and Manufacturing Technicians, and ensure compliance with SOPs safety procedures and 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. * thirty About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Mc Farland, WI
DeltaV Automation Engineer, BioPharma Manufacturing This is an exciting opportunity responsible for performing a broad set of automation & controls systems engineering activities within a major Maryland based state-of-the-art large scale commercial biologics manufacturing facility. You will be charged with overseeing the following activities: * Developing and implementing Emerson DeltaV related automation and controls systems projects within a large scale commercial manufacturing plant. * Performing process engineering and maintenance engineering activities working with process control equipment and systems including PLC, HMI, DeltaV and other MES systems. * Implementing and performing automation and control systems engineering activities involving large scale upstream mammalian cell culture, downstream protein purification, and BioPharmaceutical Manufacturing processes. * Creating S88 batch recipes and S88 standards. * Interfacing and integrating with MES and ERP Systems through ISA-95 & S95 Standards. * Providing outstanding equipment troubleshooting activities. Desired Skills: * BS degree in Biochemical Engineering, Chemical Engineering, Electrical Engineering, Mechanical Engineering or related Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Expertise with process control and automation systems including the Emerson DeltaV automation systems. * Expertise creating S88 batch recipes and S88 standards. * Experience programming DeltaV, PLC and HMI systems. * Excellent equipment validation, facility validation and IQ/OQ/PQ experience. * Expertise understanding engineering documentation including P&IDs and SOPs. * Expertise working with MES systems including Werum PAS-X or Emerson Syncade a plus. * Expertise working within cGMP compliance and providing exceptional GMP documentation. * thirty About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Mc Farland, WI
Director, Quality Assurance Validation, 0057735 null About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Bloomington, IN
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. * thirty About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Chicago, IL
Manager, MS&T Process Engineering null About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Mc Farland, WI
Manager, MS&T Technology Transfer null About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Mc Farland, WI
Principal Engineer, MS&T, Technology Transfer null About the Company: This is an outstanding opportunity with an expanding best in class Midwest based mammalian cell culture biologics CMO. A comprehensive benefits package is offered with this position. * Please note - This position is located in the US Midwest, not in Chicago. A full relocation package is offered for this position. *	Mc Farland, WI
Scientist 2 In Vitro null 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.
Principal Scientist, In Vivo Pharmacokinetics This is a stellar Study Director Position leading the Development team in the In Vivo Pharmacokinetics package for a long-standing research organization in Massachusetts. You will be responsible for working closely with client scientists and team, leading the strategic development of the studies, providing scientific direction for the technical aspects of studies, which include PK screening, optimization, analysis, and interpretation. Preferred Candidate Background and Expertise: * B.A./ B.S., required and Ph.D. preferred in Pharmacology, Pathology, Physiology, Biology, Oncology or related life science field. * 8+ years of Academic, Pharmaceutical, Biotechnology, or Biopharmaceutical industry experience OR equivalent combination of education and education. * Knowledge of Regulatory Requirements, SOPs and GLPs. * Understanding of Business Processes and ability to handle multiple projects. * Understanding of DMPK, ADME, LC-MS/MS, quantitative bioanalysis, bioanalytical, PK * Ability to use NCA using Phoenix WinNonlin software. Desired Skills: * B.A./ B.S., required and Ph.D. preferred in Pharmacology, Pathology, Physiology, Biology, Oncology or related life science field. * 8+ years of Academic, Pharmaceutical, Biotechnology, or Biopharmaceutical industry experience OR equivalent combination of education and education. * Knowledge of Regulatory Requirements, SOPs and GLPs. * Understanding of Business Processes and ability to handle multiple projects. * Understanding of DMPK, ADME, LC-MS/MS, quantitative bioanalysis, bioanalytical, PK * Ability to use NCA using Phoenix WinNonlin software. * 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.	Worcester, MA
Sr. Project Manager, Pharma Business Optimization Responsible for ensuring successful project launch, execution and completion of assigned projects and or programs across the global biologics business. Lead assigned internal and external resources to solve key business challenges and implement targeted business solutions. Influence and interact with all levels within the business. Prepare and organize key financial data as required related to the project and delivery outcomes. Prepare project presentations for monthly business reviews and or senior management reviews. Prepare, organize and maintain project plans in CRL platforms (Smartsheet) and schedules for project tracking. Responsible for recognizing potential project delays in advance and propose solutions to mitigate the impact with the project team. Ability to work with all levels of scientific, operational, quality assurance and sales/marketing personnel globally to develop project process steps, timelines and deliverables to execute the project. Ability to hold project team members and resources accountable for process step delivery and execution through controlled action tracking and follow up. Maintain projects on time, managing expectations and risk and monitoring post project benefits Desired Skills: Bachelor's degree (B.A./B.S.) or equivalent in a scientific, engineering, finance or related field. 7-10 years related experience, with a minimum of five years in a project management role demonstrating successful delivery of complex projects An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Lean Six Sigma Green Belt, PMP certification preferred Demonstrated leadership skills and knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries is required. Must have working knowledge of Project Management solutions (i.e. Microsoft project, SmartSheets) and general database applications. May be required to wear personal protective equipment (PPE) according to OSHA regulations and company standards Must have MS Office Suite experience . Must regularly communicate with employees/customers; must be able to exchange accurate information. This position requires occasional domestic and international travel. 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.	Philadelphia, PA
Associate Director/Director Quality Control Lab Manager Provide technical guidance to staff, scientists and clients as needed. Day to day oversight to ensure on-time delivery of all client projects related to biosafety testing services. Work within and external to the group to resolve scientific and technical issues. Oversee acquisition and implementation of new technologies. Desired Skills: Bachelor?s degree (BS/BA) or equivalent in biology, virology or related discipline 10+ years of experience in contract laboratory environment operation in a cGMP environment. Prior supervisory/management experience required. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Demonstrated leadership skills and knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries is required. 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.	Philadelphia, PA
Manager Mammalian Cell Banking, BioPharma Manufacturing This is an exciting opportunity responsible for overseeing Mammalian Cell Banking within a leading Biologics testing and manufacturing organization. You will be charged with overseeing Supervisors and Staff responsible for cell banking operations. You will also be responsible for the following activities: * Overseeing GMP Manufacturing for both upstream cell culture and downstream purification processes. * Overseeing mammalian cell banking operations including seed stocks and production in shake flasts, T-flasks, hyper flasks and cell stacks. * Leading a team of Supervisors among multiple clean room suites as well as production and testing schedules. * Overseeing and managing raw material and cell bank inventories. * Overseeing virus production processes involving viral purification, Ultracentrifugation and TFF. * Leading CAPAs, deviation handling and investigations. * Providing guidance to clients and customers. * Managing laboratory budgets, departmental budgets and expendatures. * Ensuring inspection readiness and the hosting of FDA & EMEA audits and inspections. Desired Skills: * BS or MS in Biology, Chemistry, Biochemistry, Microbiology or related Life Sciences field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Hands-on expertise leading mammalian cell banking operations including seed stocks and cell culture production in shake flasts, T-flasks, hyper flasks and cell stacks. * Experience leading Upstream Manufacturing Supervisors and staff. * Expertise leading CAPAs and inspections with successful experience resolving related deviations. * Experience ensuring GMP compliance, providing GMP documentation and regulatory inspection readiness. * 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.	Philadelphia, PA
Associate Director Microbiology, BioPharma This is an exciting opportunity responsible for overseeing Quality Control Microbiology activities within a leading Biologics testing and manufacturing organization. You will be charged with overseeing sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification, site contamination control as well as the following activities: * Overseeing Site Quality Control Microbiology activities within a leading Biologics testing and manufacturing organization. * Leading a team of Managers and Supervisors overseeing sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification and site contamination control activities. * 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. * Providing guidance to clients and customers. * Managing laboratory budgets, departmental budgets and expendatures. * Ensuring Microbiology related Inspection readiness and the hosting of FDA & EMEA audits and inspections. Desired Skills: * BS or MS in Microbiology, Biology, Chemistry, Biochemistry or related Life Sciences field. * 6+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Hands-on expertise leading QC microbiology testing and assays including sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification and site contamination control testing. * Experience leading Microbiology Supervisors and staff. * Expertise leading microbiology related investigations with successful experience resolving related deviations. * Experience ensuring GMP compliance, providing GMP documentation and regulatory inspection readiness. * Expertise leading microbiology related methods development, methods qualification, and methods validation activities. 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.	Philadelphia, PA
Regulatory Affairs Lead, Molecular Diagnostics This is an immediate opportunity for an experienced Regulatory Affairs Leader to manage multiple projects for premier Molecular Diagnostic and In Vitro Diagnostic development and manufacturing operations. Your responsibilities will include: * Managing projects to ensure the proper keeping of DHF (Design History Files) for FDA regulatory compliance. * Leading projects across multiple departments and groups including R&D, Manufacturing, Quality, and Regulatory Affairs. * Managing project schedules, overseeing project timelines, and detailing project activities. * Developing and generating GANTT charts to detail project tasks and project schedules. * Supporting internal audits, external audits, quality audits, non-conformance audits and inspections. * Leading IT initiatives to ensure cGMP, FDA, and ISO 13485 compliance standards. Desired Skills: * 5+ years of Project Management experience within an FDA regulated Molecular Diagnostic, In Vitro Diagnostic Laboratory, Reference Laboratory, or Medical Device manufacturing environment. * Expertise ensuring Design Control and DHF (Design History Files) are within FDA and ISO regulatory compliance. * Expertise overseeing projects involving Laboratory Information Systems (LIMS/LIS) and complex laboratory instrumentation. * BS or MS in Information Technology, Computer Science, Chemistry, Biochemistry, Microbiology, Engineering, Pharmaceutics, Biology or related field. * Expertise ensuring FDA, cGMP, IVDD, MDD, and ISO 13485 compliance. * Experience working with Microsoft Project and PMP certification a plus. * thirty	Lakewood, CA
Associate Director, CMC Project Management This is an exiting new leadership position responsible for managing key meetings for the leadership team, ensuring content is well prepared, time is effectively spent, and objectives are achieved. You will also be responsible for supporting the execution of strategic business initiatives from concept through completion under the guidance of senior leadership. Your hands on responsibilities will include: * Researching, benchmarking, and analyzing information relevant to the business and current trends * Facilitating the annual strategic planning for PDM (Pharmaceutical Development and Manufacturing), organizing the leadership offsites, and managing and engaging with leadership to innovate and refine strategies. * Working across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as supporting the resolution of issues that arise * Planning and facilitating content for All Hands meetings * Serving as the liaison between staff and senior leaders for project updates, proposals, and planning Desired Skills: * 10+ years of relevant experience and a BS, 8 years of relevant experience and an MS within the biotech/pharmaceutical industry with thorough understanding of the drug development process * CMC experience in small molecules, biologics, or antibody drug conjugates and broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies * Proven leadership and cross-functional management of CMC programs. Track record of successfully driving and managing programs, overcoming challenges and managing risks. * Strong project management skills, including proficient use of MS Project and other tools. * Demonstrated successful leadership in building teams and developing, motivating and managing talent. * Excellent people management skills with the ability to develop effective relationships, motivate others and influence in a cross-functional environment. * Collaborative team player who fosters open communication and facilitates mutual understanding and cooperation amongst all stakeholders. * Outstanding communication skills (oral, written, and interpersonal) and with the ability to negotiate and influence at all levels of the company. * Strong analytical and problem-solving skills; able to troubleshoot critical issues or problems, determine causes and identify and implement solutions. About the Company: The position is within a top West Coast BioPharma company and serves as an outstanding opportunity to drive quality analytics programs and build a road map within the PDM organization in the company.	San Mateo, CA
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: A few key benefits include: - Opportunity to grow and pave the way within a Next Generation Firm. You will see no limitations to growth potential or access to clients. This a great opportunity to maximize your overall income while contributing as a key team member of an amazing team. - We have our own killer established and efficient home built ResuWe online recruiting technologies and technology products which make it easy for you to work with the best clients and candidates. - We offer a premier training program so that you're always recruiting with best practices. - We're well connected through ResuWe, LinkedIn Recruiter, Slack and Zoom. We also have a modern professional work environment located in Aliso Viejo in close proximity to great restaurants, gyms, Aliso Woods biking trails and Trader Joes. - We are on the Insperity outsourced HR System and offer a premier suite of Medical Benefits and 401K plan rivaling the benefits level of a major corporation!	Aliso Viejo, CA
Senior Technical Specialist-Quality Control null 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 null 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
Sr Quality Control Manager, BioPharma Manufacturing This is a stellar opportunity leading a broad set of QC Biochemistry and QC Immunology tech transfer activities for large scale commercial biologics manufacturing capabilities. Your roles and responsibility will include: * Leading a team of 10-15 QC Scientists responsible for overseeing tech transfer of QC analytical methods, technical transfers and validations into large scale manufacturing. * Leading a team of QC Scientists responsible for raw material testing, in-process, lot release, and stability testing of therapeutic bulk drug substance and final drug product laboratories. * Overseeing the transfer of QC Biochemistry and QC Immunology methods and characterization including IEF, SDS PAGE, Western Blot, GC, UV, HPLC, Capilary Electropherisis (CE), and UV & IR spectroscopy methods. * Leading and mentoring Scientists responsible for analytical methods development, methods qualification, and methods validation activities. * Leading QC related technical troubleshooting including MSAT related deviation handling and investigations. * Implementing and maintaining LIMS and Laboratory Quality Systems. Desired Skills: * BS, MS, or Ph.D. in Microbiology, Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Scientific/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific leadership of Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise leading general bioanalytical, chemical and immunological test methods including IEF, SDS PAGE, Western Blot, GC, UV, HPLC, Capilary Electropherisis (CE), and UV & IR spectroscopy. * Expertise working with LIMS and Laboratory Quality Systems including Trackwise, Waters Empower, iLab or SoftMax. * Expertise leading methods development, methods qualification, OOS method investigations and methods validation activities. * Expertise working within cGMP compliance and providing GMP documentation. * 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.	Portsmouth, NH
Sr Project Specialist, GMP Manufacturing This is an exciting opportunity responsible for supporting manufacturing projects in partnership with the Manufacturing Leadership Team while participating in projects cross-functionally. You will also be supporting the achievement of department goals, interdepartmental readiness and batch release requirements, while maintaining due dates to support o time release of batches. Your responsibilities will include: * Owning and managing manufacturing process specific change controls, planned deviations, and CAPAs, while driving and owning improvement projects that support KPIs with a focus on cost, innovation, and on-time delivery and quality Setting clear timelines for project initiation, while being accountable for proposed timelines Performing validation protocol review and inventory ordering Strong understanding of continuous improvement Desired Skills:* BS in Life Science field with industry experience Ability to perform CAPA and Deviation checks regularly and use change controls as necessary Experience taking part in manufacturing specific projects and work with others in a team environment Experience taking part in system ownership for specific QC analytical equipment Experience owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time performance. 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.	Portsmouth, NH
Cell Therapy Senior Manufacturing Associate-Technical Path null 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.	Portsmouth, NH
.NET Full Stack Engineer, Healthcare Technology Solutions This is an exciting opportunity within a well funded, self sufficient, profitable local San Diego based company with major fortune 500 clients in the high growth healthcare industry. The company is on track for rapid growth due to increased client acquisition and competitive advantages in technologies. You will be responsible for delivering high quality software solutions. You will be working out of our San Diego offices in a team environment contributing to the design and execution of web and mobile products. We are looking for a self-starter who is excited to learn and improve his or her skillset in the ever-evolving medium of the web. The ideal candidate is a creative thinker with experience in user experience definition and user interface design. We?re looking for engineers that want to help us build the next great product with the mentality that our application directly impacts user?s lives for the better and helps them achieve improved health and wellness as a result. Your roles and responsibilities will also include: Build and maintain reusable code libraries Participate in technical questions in RFPs and customer engagements as and when required Set up proof-of-concepts as needed to demonstrate functionality and integration capabilities Optimize applications and frameworks for maximum speed and scalability Work with the development team to design architectural changes Participate in regular development activities as well as enhancements Respond to clients requests for changes, maintenance, reports, queries and investigations Serve as a subject matter expert, providing: guidelines, best practices and training to other individuals regarding web and mobile development, application and design Formulate concepts and ideas for additional products, tools and services that can be provided in the digital space Ability to troubleshoot execution challenges in complex projects (application, infrastructure, code quality, data and performance) and enable focused corrective actions to make the innovation successful Desired Skills: REQUIREMENTS BS or MS degree in Computer Science or equivalent Minimum of 6 years of experience in product development 3+ years of professional experience developing web/mobile applications with modern frameworks like Angular, Vue, Knockout, React, etc. Possess an advanced knowledge of web and mobile UX / UI; adhere to and extrapolate complex design systems and apply to coded pages, screens, and states Develops performant, modular, and reusable UI patterns with focus on DRY technique. Ability to interface with customers to develop and review requirements and plans Ability to create proof-of-concept solutions, supported by study of existing solutions Ability to develop technical documents related to SDLC, libraries, implementations, business and client requirements TECHNICAL KNOWLEDGE Solid background in ASP.NET / C# with a good knowledge of .NET ecosystem Web standards such as XHTML, CSS, REST, XML, JSON. Experience with CSS preprocessors such as SASS or LESS Software development lifecycle and best practices, including standards-compliant code. Familiar with version control systems like SVN or Git Experience with REST APIs Performance tuning and development of scalable solutions Good understanding of asynchronous request handling, partial page updates, AJAX, and related technologies Familiarity with design programs such as Sketch, Photoshop, Zeplin, etc. Proficient understanding of cross-browser and device compatibility issues and solutions Experience with responsive application design that performs and provides the best user experience for different devices on demand PLUSSES Knowledge of back-end design and implementation Experience with Angular 2 Experience working with Entity Framework 5+ A strong desire to be a contributing part of a growing technology team An entrepreneurial attitude that is always looking for improvements Healthcare or Wellness experience Experience with Scrum / Agile methodologies Strong organizational skills and a dedication to quality This position is available now and temporarily remote due to COVD-19. It is WFH (work from home) fully remote for the duration of the COVID-19 pandemic, but will eventually return to being office-based when conditions are safe. About the Company: - Work at a technology company that is on the cutting edge of web and mobile-based products in Health and Wellness industries - Modern new office in San Diego with IdeaPaint walls, gourmet kitchen, occasional catered lunches, quality fresh ground coffee, and excellent snacks - Mac and Windows friendly environment - Flexible work schedules including some work-from-home days - 401K, medical / dental / vision healthcare coverage, and other benefits - Business casual environment - Unlimited performance based compensation - Participation in Company Stock Option Program	San Diego, CA
Sr. Scientist, Analytical Methods Characterization This is an exciting new opportunity to join a biotechnology company that promotes health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious diseases. You will be responsible for driving analytical development activities including HPLC and Capillary Electrophoresis based methods for the development of novel Monoclonal Antibody therapeutics. Your overall responsibilities will also include: * Developing analytical methods with chromatography based HPLC and UPLC methods for use in release and stability testing of biotherapeutic clinical trial materials. * Developing, transferring and troubleshooting capillary electrophoresis methods. * Assisting with the installation, set up, troubleshooting and routine maintenance of new laboratory equipment including Agilent, Waters and Sciex HPLC, UPLC and Capillary Electrophoresis equipment. * Providing expertise in the analytical characterizing biopharmaceutical products utilizing HPLC, UPLC, Capillary Electropheresis, SEC, CEX, RP, HIC and other modern protein separation techniques. * Driving the scientific and technical development of Monoclonal Antibody therapeutics. * Applying Design of Experiments to assay optimization and qualification. Desired Skills: * BS or MS in Pharmaceutics, Pharmaceutical Technologies, Formulations, Biochemistry, Chemistry or related Scientific field. * 2+ years of Biotechnology or BioPharmaceutical industry experience. Support testing and analysis in the vaccine sciences department (run assays, perform testing, and analysis, prepare samples, maintain, and review lab documentation). Training or experience with microbiological lab techniques a plus (such as sample analysis, mammalian cell culture, cell line maintenance, passaging of cells, molecular techniques or similar relative experience). * 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
Associate Director, Commercialization GPM null 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
Scientist I, Upstream Process Development null 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/Sr Director, Regulatory Affairs, Vaccine Development This is an exciting Scientific Project Leadership opportunity responsible for overseeing CMC Regulatory Affairs activities. This position is responsible for implementing and driving all aspects of regulatory activities as needed to support the global development of investigational vaccines from clinical trials through licensure and commercialization. It's also a fantastic opportunity to work based remote within a major BioPharma company. * Serving as Regulatory CMC expert and developing regulatory strategies for IND and BLA filings. Assist with CMC regulatory submission strategies for investigational vaccine products. Driving CMC regulatory strategies, key issues and remediation activities needed throughout the project life cycle, to project teams and appropriate management levels. * Providing updates on strategic global regulatory intelligence, such as new regulations, guidance, competitive product applications and approvals. * Serving as the primary CMC regulatory representative on multiple concurrent projects. * Providing strategic and tactical support for the timely preparation, editing and review of submissions, including regulatory agency meeting requests and briefing documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements. * Ensuring all CMC Regulatory deliverables associated with each project are completed within defined timelines and meet regulatory guidelines. * Assisting with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains outstanding. Desired Skills & Experience Desired Skills: * BS, MS or Ph.D. in Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Life Sciences field. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong expertise and understanding of global CMC regulations, processes and issues in biologic drug development. * Background in vaccine development with knowledge of vaccine drug product development highly desirable. * Experience contributing to BLA regulatory filings. * Successful experience managing at least 1 application through licensure (BLA or MAA) and in post-marketing including working understanding of ICH CTD structure and content for clinical, nonclinical, and quality. * Expertise working within cGMP compliance and providing GMP documentation. * 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 Manager/AD Regulatory Affairs null 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
Associate Director, Regulatory Affairs, CMC Drug Product This is an exciting Scientific Project Leadership opportunity responsible for overseeing CMC Regulatory Affairs activities. This position will work in close collaboration with the Senior Director Regulatory Affairs CMC to implement and coordinate all aspects of regulatory activities as needed to support the global development of investigational vaccines through licensure and beyond. * Serving as Regulatory CMC expert and developing regulatory strategies for IND and BLA filings. Assist with CMC regulatory submission strategies for investigational vaccine products. Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project life cycle, to project teams and appropriate management levels. * Providing updates on strategic global regulatory intelligence, such as new regulations, guidance, competitive product applications and approvals. * Serving as the primary CMC regulatory representative on multiple concurrent projects. * Providing strategic and tactical support for the timely preparation, editing and review of submissions, including regulatory agency meeting requests and briefing documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements. * Ensuring all CMC Regulatory deliverables associated with each project are completed within defined timelines and meet regulatory guidelines. * Assisting with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains outstanding. Desired Skills: BS, MS or Ph.D. in Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Life Sciences field. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong expertise and understanding of global CMC regulations, processes and issues in biologic drug development. Background in vaccine development with knowledge of vaccine drug product development highly desirable. Experience contributing to BLA regulatory filings. * Expertise working within cGMP compliance and providing GMP documentation. * 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
Sr QC Analyst, BioPharma Development We are seeking an Experienced Senior Quality Control Analyst to join our Quality Control team. Your roles and responsibilities will include: * Developing and implementing product control strategies, QC specifications, stability acceptance criteria, reference standards and analytical comparability studies for biologics development and GMP manufacturing processes. * Identifying product quality attributes and defining phase-appropriate product monitoring and data trending strategies. * Leading QC stability studies performed according to ICH standards. * Driving and leading stability data trending, detection and reporting of trends and investigations in response to unusual or unexpected deviations. * Overseeing programs and procedures which assure the continuity of qualified product reference standards for monoclonal antibody therapeutics and antibody drug conjugates. * Leading analytical methods qualification, methods validation activities and tech transfer activities with external contract manufacturers. * Providing expertise and technical leadership for troubleshooting product quality deviations impacting non-conformance and out of specification investigations. Desired Skills: Minimum of a degree or equivalent in a scientific discipline 6+ years of industry experience in a cGMP laboratory, preferably related to biopharma industry operations Hands on experience performing ELISA in a cGMP environment Hands on experience performing SDS-PAGE in a cGMP environment Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required 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
AD/Director Alliance Management null 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
Site Quality Leader, Complex Nutritional Food Manufacturing This is a key leadership opportunity serving as Head of Quality and Plant Quality Site Leader. You will be responsible for driving and overseeing a broad set of Quality Systems for complex nutritional foods manufacturing. Your overall Quality responsibilities will include leading Quality Assurance, Quality Control laboratories, Investigations, Root Cause Analysis & Resolution, and Quality Compliance functions. Your overall responsibilities will include: * Serving as Head of Quality and Plant Quality Site Leader and a key member of the plant leadership team. * Directing a team of 5 direct reports and total staff of 60+ employees. * Developing Quality program strategies and managing day-to-day implementation and execution of cGMP compliance, HACCP compliance, Master Sanitation Schedules, Chemical Management and Integrated Pest Management. * Developing Quality Key Performance Indicators (KPI) and working with plant leadership team to meet and exceed KPIs. * Leading root cause analysis and deviation investigations for out-of-specification results & data. * Overseeing Quality Control laboratory testing for finished product, intermediate, stability, in-process, physical properties, and analytical chemistry testing. * Ensuring Quality Systems and laboratory operations are compliant with FDA, CGMP, and local regulations. * Developing and implementing continuous improvement strategies and methods to improve plant quality. * Representing QA and Quality departments to support capital project improvements and changes. Desired Skills: * 8+ years of Nutritional Foods, Nutraceutical, or Food Industry Quality leadership experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Food Science, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Experience overseeing and managing Quality Assurance or Quality Systems department at the plant level. * Experience overseeing Quality Control and QC Microbiology laboratory testing for sensory, physical properties, and analytical chemistry testing. * Experience ensuring compliance with FDA, cGMP, HACCP and local regulations. * Quality Assurance leadership experience overseeing Batch Review, Deviation Investigations, CAPA Systems, SPC, and Manufacturing Support. * Experience leading internal audits, external audits and inspections. * Experience driving continuous improvement initiatives. Lean Six Sigma Green Belt a plus. * 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
Sr. Project Engineer, Complex Nutritional Foods Manufacturing This is a stellar opportunity within an established, thriving and growing complex food production company! You will be responsible for leading plant-wide processing and packaging related engineering projects for the successful manufacturing of brand name complex food products. Your hands on responsibilities will also include: * Overseeing projects including new construction, equipment upgrades, equipment installations, and entire manufacturing line installations. * Leading $10-20 M capital projects and process improvements involving food production and packaging equipment including blending systems, mixing tanks, steam injectors, spray dryers, liquid processing tanks, conveyors, and palletizers. * Leading and designing project budgets, schedules, construction, commissioning, and project take-over activities. * Managing project costs, cost proposals, project budgets, and capital budgets. * Leading and managing cengineers, contractors, and external vendors. * Providing cGMP and GMP documentation activities, writing SOPs, and developing PFD and P&ID, equipment and piping layout, and process and equipment specifications for bids. Desired Skills: * BS or MS degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering or related Engineering field. * Over 5 years of Food Processing industry experience. * Exceptional Project Management, Project Leadership, Process Improvement, and Capital Project Management experience. * Engineering expertise working with manufacturing facilities, utilities, HVAC, and electrical systems. * Process Improvement experience implementing Six Sigma methodologies involving Process Mapping, CTQ, Root Cause Analysis, Control Charts and Statistical Process Control (SPC). Six Sigma Green Belt or Six Sigma Black Belt a plus. * Expertise working within cGMP, FDA, HACCP & OSHA compliance and providing appropriate engineering documentation & SOPs. * PMP Certification a plus. * 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
Associate Director, Quality, Complex Nutritional Food Manufacturing This is a key leadership opportunity serving as Head of Quality and Plant Quality Site Leader. You will be responsible for driving and overseeing a broad set of Quality Systems for complex nutritional foods manufacturing. Your overall Quality responsibilities will include leading Quality Assurance, Quality Control laboratories, Investigations, Root Cause Analysis & Resolution, and Quality Compliance functions. Your overall responsibilities will include: * Serving as Head of Quality and Plant Quality Site Leader and a key member of the plant leadership team. * Directing a team of 5 direct reports and total staff of 50+ employees. * Developing Quality program strategies and managing day-to-day implementation and execution of cGMP compliance, HACCP compliance, Master Sanitation Schedules, Chemical Management and Integrated Pest Management. * Developing Quality Key Performance Indicators (KPI) and working with plant leadership team to meet and exceed KPIs. * Leading root cause analysis and deviation investigations for out-of-specification results & data. * Overseeing Quality Control laboratory testing for finished product, intermediate, stability, in-process, physical properties, and analytical chemistry testing. * Ensuring Quality Systems and laboratory operations are compliant with FDA, CGMP, and local regulations. * Developing and implementing continuous improvement strategies and methods to improve plant quality. * Representing QA and Quality departments to support capital project improvements and changes. Desired Skills: * 10+ years of Nutritional Foods, Nutraceutical, or Food Industry Quality leadership experience. * BS, MS or Ph.D. in Chemistry, Biochemistry, Microbiology, Food Science, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Experience overseeing and managing Quality Assurance or Quality Systems department at the plant level. * Experience overseeing Quality Control and QC Microbiology laboratory testing for sensory, physical properties, and analytical chemistry testing. * Experience ensuring compliance with FDA, cGMP, HACCP and local regulations. * Quality Assurance leadership experience overseeing Batch Review, Deviation Investigations, CAPA Systems, SPC, and Manufacturing Support. * Experience leading internal audits, external audits and inspections. * Experience driving continuous improvement initiatives. Lean Six Sigma Green Belt 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
MSAT Team (DS/DP/TT) null About the Company:	San Francisco, CA
Chief Strategy Officer null About the Company:	Los Angeles, CA
Board Member for Cell Therapies null About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	Los Angeles, CA
Director QC Stability, BioPharma Manufacturing This is an exciting opportunity responsible for overseeing all Site Quality Control Stability activities for late stage manufacturing of monoclonal antibodies. This is a once-in-a-lifetime expatriate position working abroad within a successful global BioPharmaceutical development and manufacturing organization. You will be charged with overseeing the following activities: * Overseeing Quality Control Stability Operations within a late stage mammalian cell culture manufacturing environment. * Leading stability studies performed according to ICH standards. * Providing oversight for timely stability data trending, detection and reporting of trends and investigations in response to unusual or unexpected deviations. * Overseeing programs and procedures which assure the continuity of qualified product reference standards for monoclonal antibody therapeutics and antibody drug conjugates. * Leading a team of staff responsible for stability testing activities. * Leading projects for setting up new QC laboratories including new equipment qualification and validation. * Leading analytical methods qualification, methods validation activities and tech transfer activities with external contract manufacturers. * Leading QC related technical troubleshooting including deviation handling and investigations. * Working with software vendors to set up Laboratory Information Systems (LIMS) for stability data and data trending. * Contributing to regulatory submissions for stability data including IND and BLA filings. * Ensuring Lab Safety, Pre-Approval Inspection/PAI readiness and hosting of FDA audits & inspections. Desired Skills: * BS or MS in Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Scientific/Engineering field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific and Engineering expertise working in Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise in QC testing, methods development, and characterization including biochemical, chromotographic, electrophoretic, ELISA, Western Blot, PCR, bioassays, and cell-based assays. * Expertise leading QC methods development, methods qualification, and methods validation activities. * Experience ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA audits & inspections. * Expertise working with or setting up Laboratory Information Systems (LIMS) for QC stability data. * Expertise working within cGMP compliance and providing GMP documentation. * thirty About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	Los Angeles, CA
Sr Manager, Drug Product Project Management & Tech Transfer This is an exciting foreign expatriate opportunity responsible for leading Project Management and Tech Transfer related drug product and fill/finish manufacturing activities. This is a once-in-a-lifetime expatriate leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity. You will be charged with overseeing the following activities: * Serving as a primary point of contact for communications between external Clients and internal teams to facilitate tech transfer projects. * Managing Project schedules and business processes with clients. * Managing regular weekly and monthly client communications relating to forecasting, manufacturing schedules, change controls, deviations, risk assessments and mitigations. * Overseeing Project Change Request management. * Managing Core Teams and cross functional client communications for critical issues. * Managing campaign readiness and commercial batch tracking. * Providing technical leadership and subject matter expertise relating to drug product fill & finish related deviations, change controls, process optimization, and technical troubleshooting. * Working cross functionally with Process Development, Manufacturing, Quality and Regulatory departments relating to drug product fill & finish related process improvements, process change controls and deviation investigations. Desired Skills: * BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Project Management leadership experience managing tech transfer processes between client companies and CMOs. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Drug Product technical/scientific expertise working with high speed aseptic liquid filling of vials, aseptic lyophilization filling of vials, and aseptic preparation of pre-filled syringes through capping, bottling, and packaging processes. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Quality, Regulatory and Engineering Services departments. * Expertise involving QbD (Quality by Design), Lean Manufacturing and Six Sigma methodologies. * thirty About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
LNP (lipid nano particle) delivery null About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Diego, CA
mRNA Scientist null About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	Glendora, CA
Facility Quality Manager null About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Lead/Principal Scientist, DS3 MSAT Team, Analytical Group null About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Director Drug Product Quality 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 10-15 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: * 10+ 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. About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Sr Scientist/Director, Downstream MSAT - Expat in South Korea This is an exciting foreign expatriate leadership opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related downstream purification manufacturing activities for large scale clinical and commercial recombinant protein manufacturing. This is a once-in-a-lifetime expatriate leadership opportunity within the World's Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity. Your roles and responsibility will include: * Leading MSAT staff and projects relating to downstream purification manufacturing operations. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing technical leadership and subject matter expertise relating to downstream 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 lead downstream related process improvement, process validation, process change control, deviation investigation and process characterization activities. * 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. * Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical measurements of Cp, Cpk, Pp, and Ppk. * Training downstream 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 Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Microbiology, Chemistry or related Life Sciences/Engineering field. * 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 downstream protein purification manufacturing activities involving 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: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Director/Sr. Director, Downstream Purification Manufacturing Operations This is an exciting international expat opportunity responsible for overseeing cGMP Downstream Purification Manufacturing for large scale commercial recombinant protein manufacturing. This position is immediately available due to major company and plant expansions. This is a once-in-a-lifetime expatriate leadership opportunity within the World's Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity. Your roles and responsibility will include: * Directing the scheduling of purification operations and downstream personnel while working within cGMP compliance and meeting quality standards. * Providing Technical/Scientific leadership for downstream protein purification activities ranging from column chromatography, filtration (UF, DF, TFF), harvest and recovery. * Training purification staff on cGMP compliance and SOPs including writing/reviewing batch records, ordering of raw materials, maintaining buffer inventory, writing/reviewing User Requirement Specifications (URSs), and setting up production batches. * Working with Manufacturing, Regulatory, and Quality teams to lead downstream related process improvement, process validation, and process characterization activities. * Directing downstream purification activities ranging from harvest, filtration, chromatography, viral clearance and recovery operations. * Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting. * Coaching, mentoring, and managing downstream purification teams/staff by establishing performance standards, evaluating performance, and determining employee responsibilities. Desired Skills: * BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific and Engineering leadership experience managing downstream protein purification manufacturing activities involving 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, statistical analysis, and process robustness studies. * Experience ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA/EMEA audits & inspections. About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
SBL2020 - Korean American - MSAT, QA, QC, Manufacturing, PM null About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Scientist/Sr. Scientist/Principal Scientist, Mammalian Cell Line Development This is an exceptional opportunity responsible for providing Scientific expertise towards the development of novel mammalian cell line development and mammalian expression technologies. You will be directly responsible for performing cell line development process development activities ranging from vector development, screening, transfections, media optimization, development of stable cell lines and cell banking activities. You will also be responsible for performing antibody characterization activities including ELISA, SDS-PAGE, western blot, and Octet techniques. This is a key position instrumental in progressing select monoclonal antibody and biosimilar therapeutic candidates from early to late stage clinical trials. Desired Skills: * BS, MS or Ph.D. in Cell Biology, Molecular Biology, Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific and Engineering expertise developing mammalian cell line optimization and mammalian expression technologies for the generation of monoclonal antibody and recombinant protein therapeutic products. * Strong understanding of mammalian cellular physiology and mammalian expression systems. * Expertise working with a variety of cell lines and mammalian expression systems including CHO and NS0. * Expertise performing antibody characterization activities including ELISA, SDS-PAGE, western blot, and Octet techniques. About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	Princeton, NJ
Sr Manager QC Stability, BioPharma Manufacturing This is an exciting opportunity responsible for overseeing all Site Quality Control Stability activities for late stage manufacturing of monoclonal antibodies. This is a once-in-a-lifetime expatriate position working abroad within a successful global BioPharmaceutical development and manufacturing organization. You will be charged with overseeing the following activities: * Overseeing Quality Control Stability Operations within a late stage mammalian cell culture manufacturing environment. * Leading stability studies performed according to ICH standards. * Providing oversight for timely stability data trending, detection and reporting of trends and investigations in response to unusual or unexpected deviations. * Overseeing programs and procedures which assure the continuity of qualified product reference standards for monoclonal antibody therapeutics and antibody drug conjugates. * Leading a team of staff responsible for stability testing activities. * Leading projects for setting up new QC laboratories including new equipment qualification and validation. * Leading analytical methods qualification, methods validation activities and tech transfer activities with external contract manufacturers. * Leading QC related technical troubleshooting including deviation handling and investigations. * Working with software vendors to set up Laboratory Information Systems (LIMS) for stability data and data trending. * Contributing to regulatory submissions for stability data including IND and BLA filings. * Ensuring Lab Safety, Pre-Approval Inspection/PAI readiness and hosting of FDA audits & inspections. Desired Skills: * BS or MS in Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Scientific/Engineering field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific and Engineering expertise working in Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise in QC testing, methods development, and characterization including biochemical, chromotographic, electrophoretic, ELISA, Western Blot, PCR, bioassays, and cell-based assays. * Expertise leading QC methods development, methods qualification, and methods validation activities. * Experience ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA audits & inspections. * Expertise working with or setting up Laboratory Information Systems (LIMS) for QC stability data. * Expertise working within cGMP compliance and providing GMP documentation. About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	Los Angeles, CA
Site QC Microbiologist, BioPharma Manufacturing 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: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	Malvern, PA
Sr. Director, Quality Control, BioPharma Manufacturing This is an exciting US expatriate leadership position responsible for overseeing Quality Control operations within a new startup plant within a best in class Global Contract Manufacturing Organization (CMO). You will be charged with overseeing the following activities: * Overseeing Quality Control Operations within a multi-plant large scale mammalian cell culture manufacturing environment with 180KL to 360KL commercial manufacturing capacity. * Overseeing the strategic direction and Quality Control Department strategy in support of the company Quality vision. * Leading a team of managers and staff responsible for in-process, lot release, stability, environmental monitoring and microbiology testing of therapeutic bulk drug substance and final drug products. * Leading projects for setting up new QC laboratories including new equipment qualification and validation. * Leading QC testing, methods development, and characterization including biochemical, chromotographic, electrophoretic, ELISA, Western Blot, PCR, bioassays, and cell-based assays. * Leading QC Microbiology activities. * 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, Analytical Chemistry, Molecular Biology, or related Scientific/Engineering field. * 15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific and Engineering expertise leading Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise leading QC testing, methods development, and characterization including biochemical, chromotographic, electrophoretic, ELISA, Western Blot, PCR, bioassays, and cell-based assays. * Expertise leading QC methods development, methods qualification, and methods validation activities. * Experience ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA/EMEA audits & inspections. * Expertise working within cGMP compliance and providing GMP documentation. About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Sr Manager, cGMP Compliance, BioPharma Manufacturing - Expat Opportunity in South Korea This is a stellar opportunity responsible for leading a broad set of cGMP Quality Compliance, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities for large scale bulk biologics Commercial Manufacturing, Clinical Development Manufacturing and Drug Product Fill/Finish capabilities. This is a once-in-a-lifetime expatriate leadership opportunity within the World?s Largest biologics CMO with 362,000L mammalian cell culture manufacturing capacity plus the addition of a new 256,000 Super Plant 4 operational in 2022. Your roles and responsibility will include: * Leading a cGMP Quality Compliance team overseeing Internal Audits, External Audits, Customer Inspections and Regulatory Inspection activities. * Performing External Audits, Internal Audits, Customer Inspections, Vendor/Supplier Qualification and Management, Product Complaints, Deviations/CAPA, Document/Change Control and Training. * Leading Quality Compliance, Risk Mitigation and Risk Management activities including Compliance Risk Assessment as well as Process Compliance Risk Registry, Remediation and Tracking. * Providing Quality Compliance Support for product failure investigations. * Leading Supplier Quality activities ensuring vendor qualification, material qualification and negotiation of Supplier Quality Agreements. * Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance. * Leading or actively participating in regulatory inspections, inspection readiness activities, and Pre-Approval Inspections (PAI). * Working directly with global regulatory agencies including the FDA, EMA, MHRA, Health Canada, PMDA, and KFDA. Desired Skills: This is a stellar opportunity responsible for leading a broad set of cGMP Quality Compliance, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities for large scale bulk biologics Commercial Manufacturing, Clinical Development Manufacturing and Drug Product Fill/Finish capabilities. This is a once-in-a-lifetime expatriate leadership opportunity within the World?s Largest biologics CMO with 362,000L mammalian cell culture manufacturing capacity plus the addition of a new 256,000 Super Plant 4 operational in 2022. Your roles and responsibility will include: * Leading a cGMP Quality Compliance team overseeing Internal Audits, External Audits, Customer Inspections and Regulatory Inspection activities. * Performing External Audits, Internal Audits, Customer Inspections, Vendor/Supplier Qualification and Management, Product Complaints, Deviations/CAPA, Document/Change Control and Training. * Leading Quality Compliance, Risk Mitigation and Risk Management activities including Compliance Risk Assessment as well as Process Compliance Risk Registry, Remediation and Tracking. * Providing Quality Compliance Support for product failure investigations. * Leading Supplier Quality activities ensuring vendor qualification, material qualification and negotiation of Supplier Quality Agreements. * Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance. * Leading or actively participating in regulatory inspections, inspection readiness activities, and Pre-Approval Inspections (PAI). * Working directly with global regulatory agencies including the FDA, EMA, MHRA, Health Canada, PMDA, and KFDA. * thirty About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Sr. Scientist/Associate Director, Downstream MSAT, Biologics Manufacturing This is an exciting foreign expatriate leadership opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related downstream purification 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: * Leading MSAT staff and projects relating to downstream purification manufacturing operations. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing technical leadership and subject matter expertise relating to downstream 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 lead downstream related process improvement, process validation, process change control, deviation investigation and process characterization activities. * 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. * Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical measurements of Cp, Cpk, Pp, and Ppk. * Training downstream 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 Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Microbiology, Chemistry or related Life Sciences/Engineering field. * 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 downstream protein purification manufacturing activities involving 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: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Sr Scientist, Upstream Cell Culture MSAT This is an exciting foreign expatriate leadership opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related upstream mammalian cell culture 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: * Leading MSAT staff and projects relating to upstream mammalian cell culture manufacturing operations. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing technical leadership and subject matter expertise relating to downstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functinally 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. * Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical measurements of Cp, Cpk, Pp, and Ppk. * Training downstream 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 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 upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma About the Company: * 8+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. MBA a plus. * Quality Compliance experience performing internal audits and supporting client audits during regulatory inspections. * Quality experience overseeing cGMP Quality Compliance, Quality Compliance Risk Assessment, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities. * Quality experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics. * Quality leadership experience working on fill/finish operations for biologic liquid parenterals, pre-filled syringe, or protein lyophilized therapeutics a plus. * Experience hosting, leading or actively participating in 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.	San Francisco, CA
Upstream Process Development Supervisor, Pilot Operations This is an exciting new opportunity to work within a growing and collaborative center of innovation for BioProcessing. You will be responsible for leading a small team of upstream cell culture scientists and technicians responsible for leading single use bioreactor runs in pilot scale for the production of intermediate scale batches of recombinant and monoclonal antibodies. Your overall responsibilities will also include: * Leading a team of pilot operations upstream cell culture scientists and technicians. * Leading the design and development of upstream mammalian cell culture equipment such as single use bioreactors and technologies as well as upstream cell culture processes to support the production and manufacturing of recombinant proteins and monoclonal antibodies. * Leading the implementation of new equipment acquisitions, equipment upgrades and equipment maintenance in collaboration with Facilities and Engineering teams. * Developing bioreactor process development operations including mammalian cell culture media development, scaleup, harvest, recovery, process range finding, and statistical data analysis. * Collaborating with Process Development and Manufacturing departments to troubleshoot process challenges and deviations. * Writing process development reports and technology transfer protocols. * Supporting the implementation of analytical benchtop equipment, bioreactor systems, Automation Systems and software applications for mammalian cell culture control and data trending. * Using DOE software to design the experiment and analyze data and results. Desired Skills: * BS, MS or Ph.D. in Biological or Chemical Science/Engineering with 3+ years of industry experience. * Technical expertise working with 25L to 250L+ bioreactors or single use bioreactor technologies. * Direct experience working on mammalian cell culture processes utilizing various adherent cells and suspension cells such as CHO, NS0, Vero, HEK293 or hybridoma cell lines. * Strong Scientific and Engineering technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, single use bioreactor operations, harvest clarification and depth filtration. * 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 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.	Princeton, NJ
Scientist III, Process Development, 135650BR null 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.	Princeton, NJ
Scientist, Downstream Purification Process Development You will be responsible for providing Scientific leadership and project management for multiple protein purification process development, scale-up and technology transfer processes for early and late stage monoclonal antibody and recombinant protein therapeutic products. Your roles and responsibilities will also include: - Managing the optimization and characterization of early and late stage cGMP downstream protein purification activities ranging from harvest, filtration, chromatography, viral clearance and recovery. - Running technology transfer activities involve including process scale up and transfer to 3rd party Contract Manufacturing Organizations (CMO). - Overseeing downstream purification studies, scale-down studies, process validation activities, and process characterization activities for monoclonal antibody and recombinant protein drug products. - Developing and supporting processes for early Phase I, Phase II and late stage Phase III clinical trial materials. - Contributing to CMC sections of NDA & BLA filings, participating in Pre Approval Inspections, and participating in FDA audits. Desired Skills: * MS or Ph.D. in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field. * 3+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience managing downstream purification technology transfer activities with Contract Manufacturers (CMOs) and off site locations. * Strong Scientific, Engineering, and Manufacturing troubleshooting expertise involving downstream protein purification processes for the generation of monoclonal antibody and recombinant protein therapeutic products. * Expertise leading scale-up, technology transfer and process validation (PQ) activities. * Expertise involving Pre Approval Inspections (PAI) and FDA Audits. * Expertise working within cGMP compliance and providing GMP documentation. 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.	Frederick, MD
Sr. Engineer, Upstream Cell Culture Bioreactor Development This is an exciting new opportunity to work within a growing and collaborative center of innovation for BioProcessing. Your overall responsibilities will also include: * Leading the design and development of upstream mammalian cell culture equipment such as bioreactors and single use technologies as well as upstream cell culture processes to support the production and manufacturing of recombinant proteins and monoclonal antibodies. * Developing bioreactor process development including mammalian cell culture media development, scaleup, harvest, recovery, process range finding, and statistical data analysis. * Driving the development and implementation of new bioreactor technologies and innovations. * Collaborating with Process Development and Manufacturing departments to troubleshoot process challenges and deviations. * Writing process development reports and technology transfer protocols. * Supporting the implementation of analytical benchtop equipment, bioreactor systems, Automation Systems and software applications for mammalian cell culture control and data trending. * Using DOE software to design the experiment and analyze data and results. Desired Skills: * BS, MS or Ph.D. in Biological or Chemical Science/Engineering with 4+ years of industry experience. * Technical expertise working with 50L to 500L+ bioreactors or single use technologies. * Direct experience working on mammalian cell culture processes utilizing various adherent cells and suspension cells such as Vero, HEK293, CHO cells. * 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. * 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 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