| Job Title | Location |
|---|---|
| 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 |
| Sr R&D Engineering Manager, Class 3 Stent & Catheters
This is a stellar R&D Engineering leadership opportunity responsible for leading the full lifecycle development and commercialization of novel vascular stents and catheters from conceptualization through to commercial market launch. This is an exciting opportunity to lead a team of Engineers while interfacing directly with cross-functional development partners and key medical opinion leaders. You will be responsible for the following activities: * Managing and mentoring a team of Engineers responsible for R&D Engineering of novel stents and catheters. * Leading full lifecycle development processes of novel stents from conceptualization, design, prototyping, testing, clinical evaluation, manufacturing transfer and commercialization. * Leading Cross-Functional teams with Quality, Manufacturing, Marketing and Clinical Teams including the active interfacing with Physicians and Clinicians. * Leading R&D activities including the establishment of product requirements, prototyping product testing, FEA, POC, verification, validation, material selection, risk/failure assessment, and safety testing. * Ensuring FDA, GMP, and ISO compliance involving Design Control and maintenance of Design History Files (DHF). * Actively contributing to and authoring regulatory filings including PMA Submissions and applications for CE Mark. Desired Skills: * BS or MS Degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering or related Engineering field. * 8+ years of vascular/cardiovascular medical device industry experience working with vascular heart valves, catheters or stents. * Experience managing Engineering teams and Cross-Functional R&D teams. * Expertise in the design, development, and commercialization of advanced stent and catheter delivery technologies with working knowledge of FEA. * Experience contributing to and authoring regulatory filings including PMA Submissions and applications for CE Mark. * Materials expertise working with nitinol for stent design. * Strong experience utilizing Solidworks, CAD, AutoCAD and Computer Aided Design tools. * thirty About the Company: This is an exciting full time opportunity with an Orange County headquartered global medical device company which partners with physicians to innovate products designed to help patients live longer, healthier and more productive lives
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Irvine, CA |
| Sr R&D Engineer, Class 3 Stent Development
This is a stellar R&D Engineering opportunity responsible for leading the full lifecycle development and commercialization of novel vascular stents from conceptualization through to commercial market launch. You will be responsible for the following activities: * Leading full lifecycle development of novel stents from conceptualization, design, prototyping, testing, clinical evaluation, manufacturing transfer and commercialization * Leading R&D activities including the establishment of product requirements, prototyping product testing, FEA, POC, verification, validation, material selection, risk/failure assessment, and safety testing. * Leading Cross-Functional teams with Quality, Manufacturing, Marketing and Clinical Teams including the active interfacing with Physicians and Clinicians. * Ensuring FDA, GMP, and ISO compliance involving Design Control and maintenance of Design History Files (DHF). * Actively contributing to and authoring regulatory filings including PMA Submissions and applications for CE Mark. Desired Skills: * BS or MS Degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering or related Engineering field. * 4+ years of vascular/cardiovascular medical device industry experience working with vascular heart valves, catheters or stents. * Expertise in the design, development, and commercialization of advanced stent and catheter delivery technologies with working knowledge of FEA. * Experience contributing to and authoring regulatory filings including PMA Submissions and applications for CE Mark. * Materials expertise working with nitinol for stent design. * Strong experience utilizing Solidworks, CAD, AutoCAD and Computer Aided Design tools. * thirty About the Company: This is an exciting full time opportunity with an Orange County headquartered global medical device company which partners with physicians to innovate products designed to help patients live longer, healthier and more productive lives
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Irvine, CA |
| Sr Scientist/Project Leader/Director, Next Generation Plant-Based Meat Alternatives
This is an exciting Scientific growth opportunity within an ultra-innovative category defining plant-based foods and nutritional products company with new research labs and expansive growth plans. You will be charged with overseeing new product development & innovation for a new line of vegan plant-based meat and seafood alternatives from product launch through to commercialization activities. Your overall roles and responsibilities will include: - Overseeing Product Development and Innovation to introduce, develop, launch and commercialize all-natural vegan plant-based meat, poultry, fish and seafood alternatives - Partnering with marketing, scientific and technical core team members to define project scope, success criteria, and critical paths while maintaining Stage Gate methodologies from innovation, R&D, process scale up, sensory testing, product launch through to successful completion of post-launch reviews. - Understanding and leveraging the nutritional impact value of products, interpreting results and working with Marketing to further product development efforts. - Driving Scientific Marketing campaigns through content creation, PR campaigns and writing for scientific whitepapers and informational documents. - Effectively communicating scientific and technological concepts to technical and non technical audiences at multiple levels through a variety of mediums to enable sound business decisions. - Driving the success of Business Operations through forecasting, budgeting, P&L accountability, development of KPIs and e-commerce analytics. - Serving as member of the company?s leadership team overseeing and developing the emerging Health and Nutrition Science Division. Desired Skills: - 3-5+ years of successful product development and marketing experience from within plant-based meat and seafood alternatives and or food-pharma related industries. - MS or Ph.D. in Food Science, Nutritional Science, Nutrition or related scientific field. MD or MBA a plus. - Scientific/ technical nutritional product development and product innovation experience. - Successful experience building early stage plant-based meat and seafood alternatives, meatless foods, vegan foods, natural foods, plant-based foods, nutraceutical, nutritional products into category market leaders. - Project Management experience developing plant-based meat and seafood alternatives or vegan meatless food products from discovery, R&D, development, product launch through to commercialization phases. - Process Innovation expertise working with aggressive Stage-Gate methodologies. - Scientific and technical expertise working with plant-based meat technologies and processes including heme, fermentation, leghemoglobin, cultured koji, soy proteins or protein isolates. - Experience developing clinical trial protocols, scientific studies and laboratory testing methods which support marketing claims. - Strong publication, patent and presentation record. - Experience working within FDA, GMP, HACCP and CFR compliance. - Entrepreneurial, visionary and strategic leadership experience with the ability to work within a dynamic fast paced ultra innovative environment. - thirty About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| Director, DTC eCommerce, Natural Foods
This is an exciting opportunity within an ultra-innovative category defining plant-based natural food company. Key products include all-natural milked almonds, milked cashews, milked walnuts, milked hazelnuts, barista editions, coffee creamers, lattes and plant-based desserts. The ideal candidate will possess an entrepreneurial mindset, thrive in a fast-paced environment, be strategic and an analytical thinker. As the of the leader of the company?s eCommerce retail business, consumer acquisition, retention, frequency and volume of purchase per transaction are critical for success. Your overall roles and responsibilities will include: - Driving aggressive and effective direct-to-consumer e-commerce initiatives which includes expanding the digital footprint and consumer acquisition via traditional skills and innovative tactics in content, digital media marketing, SEO, SEM, UX, CX and customer service. - Working directly with internal and external third-party PR and Marketing Agency partners to drive essential marketing and creative services. - Leading Social Media Strategies beyond brand awareness to grow sales conversions. - Managing Email Marketing, third-party storefronts (Amazon, Thrive Market, Imperfect Foods, Instacart, Retail Partners, etc?) - Overseeing e-commerce operations and technologies including fulfillment, storefront, merchant processing and order processing systems including Shopify, Recharge, Finale, etc.) - Driving the success of Business Operations through forecasting, budgeting, P&L accountability, development of KPIs and eCommerce analytics. Desired Skills: - 5-10+ years of successful e-commerce marketing experience driving the online sales (direct to consumer) of FMCG (fast moving consumer goods) such as natural foods, beverage, dairy, nutritional products or related CPG products. - Successful experience building early stage natural foods or nutritional products and brands into category and market leaders. - Thorough technical expertise with Shopify systems and eCommerce operations including marketing strategies, website strategies and back-end fulfillment technologies. - Exceptional Business Operations and Financial Management experience overseeing forecasting, budgeting and accounting activities. - BS in Marketing, Business, Operations Management or related field. MBA a plus. - Exceptional team leadership, vision, initiative and a fearless drive for success. About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| Senior Process Engineer, Low Acid Aseptic Beverage Manufacturing
You will be charged with leading a wide variety of Process Engineering and Project Engineering activities within a state-of-the-art low acid aseptic manufacturing facility in the midst of aggressive plant expansion efforts. It?s an exciting opportunity to contribute to the rapid manufacturing low acid aseptic products including Almond & Plant Based Milks, Coffee Creamers, Protein Shakes, RTD Coffees, Smoothies, Energy Drinks and Soups. Your overall roles and responsibilities will include: * Providing technical subject matter expertise relating to low acid aseptic beverage manufacturing operations including change controls, process optimization, technical troubleshooting and manufacturing process changes. * Leading process improvements with beverage food production and packaging equipment including blending systems, mixing tanks, steam injectors, liquid processing tanks, fillers, conveyors, and palletizers. * Leading capital projects including new construction, equipment upgrades, equipment installations, and entire manufacturing line installations. * Managing project costs, cost proposals, project budgets, project schedules and capital budgets. * Implementing and integrating Six Sigma, Lean, QbD, and Continous Improvement resources with ongoing company initiatives and manufacturing objectives. * Driving Operational Excellence, Operational Efficiency and Lean Manufacturing initiatives. * Providing cGMP documentation, writing SOPs, and ensuring SQF, USDA and FDA regulatory compliance. Desired Skills: * BS or MS degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering or related Engineering field. * 5+ years of experience working within a low acid aseptic beverage manufacturing facility. * Engineering technical expertise working with beverage and food processing equipment including blending systems, mixing tanks, steam injectors, liquid processing tanks, Tetra Pak or Combibloc fillers, conveyors, and palletizers. * Exceptional Project Management, Project Leadership, Process Improvement, and Capital Project Management experience. * 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. * Engineering expertise programming and troubleshooting manufacturing process automation systems systems including PLC and DLC based Rockwell and Wonderware automation systems. * Expertise working within cGMP, FDA, SQF, USDA, HACCP & OSHA compliance and providing appropriate engineering documentation & SOPs. * Lean Six Sigma Black Belt, Master Black Belt Certification or PMP Certification a plus. About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| Sr. Project Manager, QA Data Science Solutions
This is a key leadership opportunity serving as Sr. Project Manager, QA Data Science Solutions. You will be responsible for driving quality analytics programs and building a road map to create better outcomes, while developing a strategic roadmap for advanced analytics in QA. Your overall responsibilities will include:
*Developing and driving the execution of an advanced Quality analytics road-map with the business and partners that anticipates and realizes the QMS information needs within PDM (Pharmaceutical Development and Manufacturing) * Partnering with PDM Data Governance initiatives as the quality systems representative for the implementation of quality systems in analytics data governance, data infrastructure, and platforms for AI/ML development * Collaborating across multiple functions and sites to identify and address business opportunities, evaluate alternative informatics technologies, and research industry best practices and emerging trends in Quality space * Programming, creating dashboards, and creating reports * Creating and managing reports, metrics, dashboards, and analysis to support various quality management review forums including data sciences techniques such as: time series forecasting, predictive analytics, natural language processing, and automated scripting Desired Skills: * 5 years of experience working with QA analytics and previous experience in an GMP environment * Preferred experience working with big data to drive better business outcomes * Data access and wrangling skills such as Python, SQL, Tableau, Spotfire and data operations fluency with cloud platforms (AWS, Azure, etc.) * Strong interpersonal and collaboration skills and positively influence employees in order to achieve results 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 |
| 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! - thirty 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 |
| 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. *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 |
| Cell Therapy Senior Manufacturing Associate-Technical Path
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About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19. |
Portsmouth, NH |
| QC Manager, BioPharma Manufacturing
This is a stellar opportunity leading a broad set of Quality Control and QC Biochemistry activities for a combination of new product development, large scale commercial biologics manufacturing capabilities. Your roles and responsibility will include: * Leading a team of QC Scientists responsible for overseeing tech transfer of QC analytical methods into the large scale manufacturing site. * Leading a team of QC Scientists responsible for QC Biochemistry, in-process, lot release, and stability testing of therapeutic bulk drug substance and final drug product laboratories. * Leading QC testing, methods development, and characterization including IEF, SDS PAGE, Western Blot, GC, UV, HPLC, Capilary Electropherisis (CE), and UV & IR spectroscopy. * Leading analytical methods development, methods qualification, and methods validation activities. * Leading QC related technical troubleshooting including deviation handling and investigations. * Ensuring (Pre-Approval Inspection) PAI readiness, hosting FDA & EMEA audits and inspections. * 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 and Engineering expertise leading Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise leading general bioanalytical and chemical 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 Waters Empower or SoftMax. * Expertise leading methods development, methods qualification, OOS method investigations 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: 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 |
| QC Lead, Empower/LIMS Administrator, R29353
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About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19. |
Portsmouth, NH |
| Front-End UX/UI 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:
Desired Skills: REQUIREMENTS
TECHNICAL KNOWLEDGE
PLUSSES
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
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San Diego, CA |
| Director of Product Development
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About the Company: This is an exciting opportunity to join a venture-backed startup rapidly involved in pioneering the future of food, while scaling up and optimizing processes to provide sustainable, safe, and humane meat products to the world. |
San Francisco, CA |
| Scientist, Upstream Process Development-Cell Culture
This is an exciting new opportunity within upstream process development responsible for developing the basis for a robust, efficient, large-scale cell culture platforms. Your overall responsibilities will also include:
*Developing and optimizing the cell culture parameters (for various cell lines) and nutrient requirement in shaker flasks and disposable bioreactors (10L, 50L, and 200L) for mammalian suspension cell growth for virus or virus like particle production. *Using DOE software to design the experiment and analyze the results for the virus or virus-like-particle yield improvement. *Writing technical reports and transfer the method and work with clinical production team to support/generate the SOPs/batch record and produce the clinical trial materials. *Supporting investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing and analyzing data and interpreting results. Desired Skills: *B.S. in Biological or Chemical Science/Engineering with 2-5 years of industry experience *2 years direct experience in mammalian cell culture with various adherent cells and suspension cells such as Vero, HEK293, CHO cells. *Experienced in serum-free media development and optimization *Experienced within batch and fed-batch cell culture and tech transfer *Experienced with scale-down model development, predictive modeling, and model validation *Knowledge and experience with operating in regulated GCLP laboratory environments and cGMP experience. *thirty About the Company: This is an exciting opportunity to join a venture-backed startup rapidly involved in pioneering the future of food, while scaling up and optimizing processes to provide sustainable, safe, and humane meat products to the world. |
San Francisco, CA |
| Senior Manager, Quality Control Analytical Technical Support
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Manager/Senior Manager, External Drug Porduct Manufacturing Operations
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Scientist/Senior Scientist, Upstream PD-NanoFlu
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Manager Operational Excellence
This is a unique opportunity responsible for leading projects and programs for driving Operational Excellence (OE) initiatives within an expanding Midwest Pharmaceutical Manufacturing organization. It's an outstanding opportunity responsible for championing positive manufacturing growth projects and process improvements using Lean Manufacturing, Continuous Improvement and Six Sigma methodologies to harmonize site-wide manufacturing processes. You will also be responsible for: * Serving in a Project Leadership role managing complex, strategic cross-functional projects for delivering Operational Excellence across a rapidly growing pharmaceutical manufacturing site. * Implementing Lean Manufacturing methodologies for Pharmaceutical Manufacturing improvement projects including line additions, manufacturing capacity improvements and cost savings initiatives. * Leading processes for selecting, scoping, prioritizing and executing projects to deliver business objectives and continuous improvements. * Driving business transformation using root cause analysis, lean and six sigma tools along with leadership competencies across the value chain. * Implementing and integrating Six Sigma, Lean, QbD, and Continous Improvement resources with ongoing corporate initiatives and manufacturing objectives. * Leading company-wide communications efforts and marketing campaigns focused on business transformation in support of the company's continuous improvement culture. * Designing and establishing KPIs, sustainable metrics, dashboards and systems for tracking and reporting of value proposition resulting from continuous improvement programs. Desired Skills: * BS in Engineering, Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutics, Formulations, Bioanalytical Chemistry or related field. * MBA a plus. * 5+ years of experience leading and championing Operational Excellence, Continuous Improvements, Lean Six Sigma improvements or related initiatives. * Experience leading manufacturing site Operational Excellence and Lean Manufacturing programs. * Experience leading Cross-functional teams partnering with departments including R&D, Quality, Finance, HR, Legal, Commercial, Manufacturing and Operations. * BioPharma, Pharmaceutical, Consumer Products or high-volume manufacturing experience with an FDA regulated cGMP/GMP Solid Dosage Pharmaceutical Manufacturing, biologics R&D, Quality or Manufacturing environment a plus * Lean Six Sigma Black Belt or Master Black Belt Certification 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, Global Program Management, CMC
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| AD/Director Alliance Management
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Statistician III
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Analytical Development Scientist II
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About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position. |
Gaithersburg, MD |
| Senior Formulations Scientist, Vaccine Development
This opportunity is with clinical-stage biopharmaceutical company creating novel products using innovative virus-like particle (VLP) and recombinant nanoparticle technology. The company has worldwide commercialization capacity and global reach to create real and lasting change in the biopharmaceutical field. You will also be responsible for:
* Development of liquid formulations for Virus-like Particles and nanoparticle based antibody products through logical screening of excipients * Screening of suitable primary packing materials and delivery devices for vaccine products * Design and execution of accelerated stability testing for vaccine product within ICH guidelines. * Analytical testing of formulation excipients, bulk formulations and final product * Development of formulation screening tools and techniques that can predict stability * Supervise and coordinate Formulation Development activities in-house and with vendors. * Supervise the activities of junior level scientists and development associates * Develop and Enforce SOPs for routine assays (SDS-PAGE, Western Blot, Chromatography ? HPLC / GC, Particle sizing, ELISA, Protein assay, UV Spectroscopy etc.) * Regular use of protein analytical techniques such CE, CD, FTIR, Fluorescence techniques, Calorimetry, and Biacore * Document results through writing, reviewing, and editing of standard operating procedures and reports * Maintain accurate records of all product development activities * Analyze and determine the applicability of laboratory data to draw conclusions and to make appropriate recommendations Desired Skills: * PhD in Pharmaceutics, Chemistry, Biology or equivalent * 4+ years of formulation or analytical development experience in biologics, vaccines, biotech, pharmaceutical R&D environment (we will also consider candidates with a Masters and 6 years experience) * Knowledge and expertise in development and characterization of nanoparticle technologies * Knowledge and expertise in principles and practice of current Good Manufacturing * Practices (cGMP) and Good Laboratory Practices (GLP). * Knowledgeable in FDA / CBER regulations regarding the manufacturing of biological and/or vaccines. * Proficient in DOE software i.e. JMP or similar. * Demonstrated verbal and written skills in communicating technical and regulatory information. * Experience in handling sterile dosage forms and aseptic preparation techniques. * Experience in aseptic development of late stage clinical products and/or commercial products a plus but not a must. * Experience in development of adjuvanted vaccines beneficial but not a must. 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 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: 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 Alliance Program Manager, Vaccine Development
This is an exciting project leadership opportunity to plan, monitor, control and manage risk for our rapidly expanding vaccine development programs. This is an opportunity to contribute to the development and manufacturing of a COVID-19 vaccine. Your roles and responsibilities will include:
* Working closely with US Government organizations and Non-Profit Organizations including BARDA, DOD, CEPI and the Gates Foundation. * Managing Grants, external funding, contracts and alliances with organizations including BARDA, DOD, CEPI and the Gates Foundation. * Organizing cross-functional activities, managing project team activities, managing timelines, and working closely with the research leadership team to prioritize and manage project activities. * Build working relationships with members of the Project team and its subteams to plan, schedule, monitor and control the execution of project activities for the vaccine programs. * Implement project management best practices to ensure on-time completion of milestones in fulfillment of corporate objectives. * Prepare project reports to internal and external stakeholders using established templates and processes; ensure submissions of key deliverables to external funding organizations. * Apply advanced project management tools and techniques for issue and risk management: identification, mitigation, and escalation through the established project governance model. Desired Skills: * PMP certification required. *Bachelors Degree required; Master's Degree preferred. degree in biological or chemical sciences preferred. * Experience managing grants, contracts and alliances with organizations including BARDA, DOD, CEPI and the Gates Foundation. * 5+ years of project management experience in the biotech and pharma industries; experience managing vaccine development programs is strongly preferred. * Experience in building and maintaining project plans using Microsoft Project is required. * Project Management experience overseeing Alliance Management activities with external partner companies. * Ability to establish collaborative working relationships across organizational disciplines, and throughout the organizational hierarchy. *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. CMC Program Manager, Global Vaccine Development
This is an exciting project leadership opportunity to plan, monitor, control and manage risk for our rapidly expanding vaccine development programs. We are seeking highly motivated Program Managers and Senior Program Managers with experience in either overall vaccine development and commercialization or functional program management in CMC who would like the opportunity to thrive, learn, and grow in a fast-paced, high-growth organization.
Location is flexible * Organizing cross-functional activities, managing project team activities, managing timelines, and working closely with the research leadership team to prioritize and manage project activities. * Build working relationships with members of the Project team and its subteams to plan, schedule, monitor and control the execution of project activities for the vaccine programs. *Implement project management best practices to ensure on-time completion of milestones in fulfillment of corporate objectives. *Prepare project reports to internal and external stakeholders using established templates and processes; ensure submissions of key deliverables to external funding organizations. *Apply advanced project management tools and techniques for issue and risk management: identification, mitigation, and escalation through the established project governance model. Desired Skills: * PMP certification is highly desirable *Bachelors Degree required; Master's Degree preferred. degree in biological or chemical sciences preferred. * 5+ years of project management experience in the biotech and pharma industries; experience managing vaccine development programs is strongly preferred. *Technical experience in either DS (API) vaccine/Ab processing or Parenteral Drug Product (Formulation) or Analytical Testing is strongly preferred. *Experience in building and maintaining project plans using Microsoft Project is required. * Ability to establish collaborative working relationships across organizational disciplines, and throughout the organizational hierarchy. *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 |
| Cross-Functional Senior Project Manager
This is a key leadership opportunity serving as Senior Project Manager. You will be responsible for leading as the primary point-of-contact and primary escalation point with client interactions. You will also be responsible for overseeing all functional services and managing the study budget. Your overall responsibilities include:
*Planning, directing, coordinating, and delivering activities for designated clinical study projects *Developing comprehensive project plans and timelines for trial execution with consistency and quality *Leading team meetings with clients and mentoring, training, and supervising staff *Coordinating and communicating with team members cross functionally including R&D, Marketing, Sales, Manufacturing, Executive Management, Quality Assurance, and Regulatory Affairs Desired Skills: *Masters degree preferred; Bachelors in science or health related field *Minimum of 7 years clinical research experience and 3 years direct project management experience *MS Project and Microsoft Office Suite preferred *Experience in managing complex and global trials *Experience in strategic planning, risk management and change management *thirty About the Company: This is an exciting opportunity to join a leading CRO as they support clients primarily engaged in the rapidly evolving of biomarker driven clinical drug development in oncology, immuno-oncology, rare or orphan disease, autoimmune, and other therapeutic areas. |
Frederick, MD |
| 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. 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 |
| MSAT Team (DS/DP/TT)
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About the Company: |
San Francisco, CA |
| Strategic Brand Manager / Marketing Manager (US/EU/LATAM/MENA)
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About the Company: |
San Francisco, CA |
| Chief Strategy Officer
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About the Company: |
Los Angeles, CA |
| SBUS PBM/Strategy/Payer Engagement (Director to VP)
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About the Company: |
Gaithersburg, MD |
| Director, Biopharma Regulatory Affairs - Based in UK
This is an exciting opportunity with a growing biotechnology organization backed by one of the worlds largest multinational corporations. You will ultimately be responsible for providing critical guidance in Regulatory Affairs in the development of novel drugs and biosimilars. You will also:
* Involved in leading and maintaining global product registration strategy and planning including initial and product life cycle management *Provides EU regulatory intelligence, strategic regulatory insight *Provide support on identifying opportunities and risks, and mitigations *Provide support on management of SBUK office. *Provide regulatory support to cross functional project teams for regulatory issues and questions and ensures that regulatory requirements are addressed *Provide support on preparing and reviewing core dossier *Provide support for major market regulatory approvals. *Provide post-market support and ensure regulatory compliance of market-released products. *Works closely with relevant functional teams to provide strategic regulatory guidance *Establishes and maintains good working relationship with regulatory agencies including EMA and industry regulatory groups in European region *Supports reviewing labeling/artwork etc. to ensure compliance with regulatoryrequirements *Provide value-added support to improve team standard operation procedures by authoring new SOP or editing existing SOP *Supervise and trains junior level employees *Works as a liaison and/or regulatory representatives to the regulatory authorities including EMA, industry association and partner companies in European region for the assigned projects/matters Desired Skills: * BS or MS in Chemistry. Biology, or related life sciences * 15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience * Deep and broad knowledge of worldwide regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals worldwide * Direct experience in preparing relevant section of IND's, BLA's, and other regulatory filings, preferable biological filings * Excellent and solid technical writing and communication skills * Familiar with monoclonal antibody manufacture platforms and filings * A proven track record of effective collaboration with regulatory agencies, including the FDA About the Company: |
San Francisco, CA |
| Sr Manager/Director, 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.
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Los Angeles, CA |
| LNP (lipid nano particle) delivery
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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.
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San Diego, CA |
| CDO Advanced Technology Group
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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.
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Glendora, CA |
| CDO Formulation Development Scientist
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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.
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Glendora, CA |
| CDO - DSP Specialist
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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.
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Glendora, CA |
| mRNA Scientist
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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.
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Glendora, CA |
| Facility Quality Manager
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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.
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San Francisco, CA |
| Lead/Principal Scientist, DS3 MSAT Team, Analytical Group
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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.
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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.
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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.
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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.
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San Francisco, CA |
| SBL2020 - Korean American - MSAT, QA, QC, Manufacturing, PM
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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.
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San Francisco, CA |
| Regulatory Affairs (SF or Korea)
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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.
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Glendora, CA |
| 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.
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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.
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San Francisco, CA |
| Procurement Manager, Biopharma Manufacturing
This is an exciting US expatriate position responsible for managing Procurement activities within an emerging Biopharmaceutical Organization backed by a major multinational corporation. They have aggressively entered the Biopharmaceutical industry and are engaged in commercial contract manufacturing. You will be charged with overseeing the following activities:
* Provide expertise in routine planning and raw material incident management * Participate in the decision of supply chain procedure improvements * Establish manufacturing production plans, handle raw material imports and establish logistical improvements. *Deal with issues related to supply & material quality issues * Monitor inventory flow. * Communicate, educate and provide necessary information to supply chain stake holders throughout the chain to achieve clarity in supply needs Desired Skills: *B.S/M.S Business, Logistics, Supply Chain, or related discipline *Pharmaceutical/Biotech experience a must *8+ years of experience in Supply Chain/Logistics *Experience in logistics specifically international supply chain *Experience in Business Objects, SAP and global planning tools *SAP/ERP system experience a plus 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.
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San Francisco, CA |
| Project Manager, BioPharma CMO Manufacturing
This is an exciting US expatriate project leadership position responsible for overseeing all drug substance development from upstream mammalian cell culture development, downstream purification development, manufacturing activities and quality systems management. This is a unique opportunity within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation. You will be charged with overseeing the following activities: * Serving as the liaison between Clients to manage new orders and production campaigns * Plan, execute, and finalize projects according to strict deadlines, milestones and within budget. * Providing team leadership on projects of all mammalian cell culture process development, downstream purification development, and analytical methods development/characterization for the generation and manufacturing of monoclonal antibody and recombinant protein therapeutic products. * Scheduling projects with QA and QC, to ensure that all processes and productions comply with regulatory guidelines as well as ensuring controlled environments are maintained for the manufacture of high-quality products. * Leading project management of complex tech transfers between client sites and manufacturing facilities. Desired Skills: *BS, or MS in Chemistry, Biochemistry, Biology, Chemical Engineering or related Life Sciences field. * 10+ years of Project Management experience as it relates to BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong background leading and managing projects for large CMOs * Expertise leading projects on upstream mammalian cell based cGMP biologics manufacturing, downstream purification, analytical methods technology transfer, and process validation activities. * Experience ensuring quality assurance, quality control and experience working within cGMP compliance and providing GMP documentation. 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.
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San Francisco, CA |
| 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.
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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.
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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. * 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.
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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.
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San Francisco, CA |
| 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 * 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. |
Saint Louis, MO |
| Associate Director, Bioanalytical Development, mAb Therapeutics
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 opportunity is with a highly innovative Southern California biotechnology company with a promising development pipeline and commercial product line. The company has pioneered an innovative technology to develop biologics using antibodies that target new biological mechanisms.
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Los Angeles, CA |