Company Job Listings

Job Title	Location
Quality Specialist-Deviations, CAPA, Change Control This is an exciting new opportunity to work within an expanding US Biologics Contract Manufacturing Organization with an extensive network of cGMP facilities in the US, Europe and Asia. It's also an exciting opportunity to lead major growth efforts due to new client acquisitions and facility expansion projects. Your overall Quality responsibilities will include site ownership of deviation, corrective and preventive action (CAPA) and change control (CC) processes supporting a commercial drug substance manufacturing site. Your overall responsibilities will include: Providing guidance to investigators executing deviation investigations and leading root cause analysis sessions to ensure direct and systemic root cause is identified for deviations Providing training in investigation and root cause analysis techniques and best practices Monitoring Deviations, CAPAs and effectiveness checks to ensure on-time closure and tracking and trending deviations and reports metrics Tracking metrics on the change control program and maintaining SOPs and other GMP documents Supporting regulatory inspections as an SME for Deviation/CAPA/CC Desired Skills:* Bachelor's degree (B.S.) or equivalent in chemistry, engineering or related life sciences field Minimum 8 years prior working experience in a Biotech/Pharmaceutical production environment is required; preferably, with at least 3 years? experience working with Deviations/CAPA/CC Strong knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH Q7, ICH Q10, 21 CFR 210 and 211, 21 CFR Part 11, 21 CFR 600 and 610 Proven technical writing skills and ability to conduct root cause analysis and risk assessments Experience interacting with FDA or other regulatory agencies and experience with TrackWise preferred About the Company:* This is an exciting new opportunity to work within an expanding US Biologics Contract Manufacturing Organization with an extensive network of cGMP facilities in the US, Europe and Asia. It's also an exciting opportunity to lead major growth efforts due to new client acquisitions and facility expansion projects.	Boulder, CO
Associate Director Bioassays, Antibody Drug Development This is a unique scientific leadership opportunity charged with driving therapeutic antibody drug development efforts utilizing advanced bioassays, immunoassays and cell based assay methods. Your overall responsibilities will also include: * Driving the development of state-of-the-art bioassays, immunoassays, and cell based assays for analytical methods implementation, validation, qualification, technology transfer, and protein characterization activities. * Managing a team of 10-12 Scientists developing advanced bioassays, immunoassays, and cell based assays. * Driving bioassay development efforts for cell based assays, functional assays and immunoassays including target binding assays, proliferation assays and Fc effector function reporter assays. * Developing and leading biological characterization strategies for monoclonal antibody therapeutics from R&D stages, IND stages through to BLA and commercialization. * Leading contributions to CMC sections of regulatory filings including IND, NDA, and BLA submissions. * Leading assay optimization, validation and transfer of validated bioassay methods to CROs and commercial QC laboratories. Desired Skills: * Ph.D. in Immunology, Cell Biology, Molecular Biology or related Life Sciences field. * 10+ years of BioPharma industry experience developing biologic therapeutics including recombinant proteins, monoclonal antibodies, antibody drug conjugates or fusion protein drug products. * Experience leading Scientists developing and validating bioassays, cell-based assays and immunoassays including ELISA, Biacore, SPR, ADCC or CDCC assays. * Exceptional Scientific leadership experience. * Expertise developing advanced potency assays, functional assays, structural assays, proliferation assays and binding assays. * Drug Development experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired. * Experience working on technology transfer and validation activities. * Experience supporting Commercial QC analytical test methods and working within GMP/cGMP and GLP compliance. About the Company: The position is within a top East Coast BioPharma company that is rapidly growing its development pipeline and commercial product line. This is an outstanding opportunity to develop a promising pipeline of monoclonal antibody and recombinant protein therapeutic products. A comprehensive benefits package is offered with this position.	Princeton, NJ
General Manager/VP, Branding and Operations, Natural Plant Based Beverages This is a unique leadership growth opportunity an ultra-innovative category defining all-natural food and beverage products spin-off company with award winning plant-based products. New products just launched include an all-natural Hemp Coffee Creamer, Barista Blend Milked Oats and clean label RTD chocolate peanut protein shakes. You will be charged with overseeing and growing product sales, international sales, forecasting, finance, digital marketing, and branding activities. Your overall roles and responsibilities will include: - Serving as a Chief Brand Builder and Brand Strategist for the launching innovative all-natural food and beverage product brands in RTD beverage, barista blend and coffee creamer categories. - Leading the development of strategic marketing and branding initiatives for the rapid growth of award winning plant-based beverage products sold through National Retail, Food Service and eCommerce channels. - Directing Marketing and Brand Building strategies to ensure the attainment of revenue and profit goals with responsibility for profit & loss and the achievement of current and long-range objectives. - Developing and driving marketing goals, product branding, promotions and merchandising strategies targeting an active and healthy lifestyle demographic. - Driving brand positioning and activation, segmentation analysis, new product development, commercialization, strategic planning, budgeting, forecasting, P&L responsibilities and, market data analysis. - Driving the success of Business Operations through forecasting, budgeting, P&L accountability, development of KPIs and sales analytics. - Driving International Sales including into Canada, Europe and Israel global markets. - Serving as key driver of the company?s leadership team advancing the vision of the low acid aseptic beverage manufacturing and operational strategy in conjunction with the company?s long-term plans. Desired Skills: - 10+ years of successful food product marketing experience driving sales of 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. - Experience launching, promoting and developing innovative beverage categories including plant-based beverages, functional foods, cold brew coffee, probiotics, almond milk, non-dairy alternatives, sports nutritional beverages, kombucha, hemp products or low-acid aseptic beverages. - Knowledge and experience overseeing digital sales strategies, online content, website strategies and e-commerce technologies. - Entrepreneurial and strategic leadership experience with the ability to work within a dynamic fast paced ultra innovative environment. - 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 leadership, vision, entrepreneurial spirit and 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
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. 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. - 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.	Gardena, CA
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
Senior Associate, AD, 30602 null About the Company: This is an exciting opportunity to join a major BioPharma and Vaccine company rapidly developing and commercializing novel vaccines including a vaccine for COVID-19.	San Diego, CA
Scientist, Analytical Development, 30604 null About the Company: This is an exciting opportunity to join a major BioPharma and Vaccine company rapidly developing and commercializing novel vaccines including a vaccine for COVID-19.	San Diego, CA
Senior Scientist, Immunoassay Development This is an exciting new opportunity within an established and expanding Southern California based BioPharma company. You will be responsible for driving analytical development activities utilizing stateof- the-art bioassays, immunoassays, and cell based assays for the development of novel Monoclonal Antibody therapeutics. Your overall responsibilities will also include: * Driving the development, troubleshooting and validation of state-of-the-art bioassays, immunoassays, and cell based assays for analytical methods implementation, validation, qualification, technology transfer, and protein characterization activities. * Driving bioassay development efforts for cell based assays, functional assays and immunoassays including ligand binding immunoassays, immunogenicity assays, ELISA, DELFIA, TRF and MSD immunoassays. * Developing and leading biological characterization strategies for monoclonal antibody therapeutics from R&D stages, IND stages through to BLA and commercialization. * Leading assay optimization, validation and transfer of validated bioassay methods to CROs and commercial QC laboratories. * Driving the scientific and technical development of Monoclonal Antibody therapeutics. * Applying Design of Experiments to assay optimization and qualification. Desired Skills: * Ph.D. or MS in Pharmaceutics, Pharmaceutical Technologies, Formulations, Biochemistry, Chemistry or related Scientific field. * 3+ years of Biotechnology or BioPharmaceutical industry experience. * Experience in the design, development, optimization, qualification, and transfer of cell based assays, functional assays and immunoassays including ligand binding immunoassays, immunogenicity assays, ELISA, DELFIA, TRF and MSD immunoassays. * Drug Development experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired. * Expertise working with software and data analysis packages including SoftMax Pro, WinNonLin, GraphPad Prism or JMP. * Scientific & Technical leadership experience developing Monoclonal Antibody therapeutics. * Experience applying Design of Experiments to assay optimization and qualification. * thirty About the Company: This is an exciting opportunity to join a major BioPharma and Vaccine company rapidly developing and commercializing novel vaccines including a vaccine for COVID-19.	San Diego, CA
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. * thirty About the Company: This is an exciting opportunity to join a major BioPharma and Vaccine company rapidly developing and commercializing novel vaccines including a vaccine for COVID-19.	San Diego, CA
Scientist-Upstream Process Development This is an exciting new opportunity within upstream process development responsible for leading the efforts for developing and optimizing cell culture process including media development, feeding strategies, process parameters optimization, process characterization and scale-up for large scale production to support vaccine development from preclinical through Phase III, and commercialization. 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. Participating in cross-functional project teams while leading to guide/train junior level associates. Desired Skills:* PhD with minimal 2 years relevant experience, M.S. with 8 years, or B.S. with 10 years relevant experience in industry setting. 2 years direct experience in mammalian cell culture with various adherent cells and suspention cells such as Vero, HEK293, CHO cells. Bioreactor (small scale and large scale) experience required with DoE experience 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 major BioPharma and Vaccine company rapidly developing and commercializing novel vaccines including a vaccine for COVID-19.	San Diego, CA
Senior Associate, AD-Raw Materials Testing This is an exciting new opportunity responsible for performing inspection and release testing of raw materials and packaging components as per USP/EP compendial test methods and standard test methods. You will be performing GMP testing as required in support of release and stability of API and finished drug product. Your overall responsibilities will also include: Performing identification, assay and limit testing of raw materials to support GMP manufacturing requirements and performing common analysis techniques including analytical balance, FTIR, pH measurement, UV-VIS spectrophotometer and manual titrations. Preparing specifications, SOPs, and method verification protocols and reports and performing required data analysis. Performing facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems. Maintaining clean and sanitary work area. Presenting data to communicate findings to internal groups and management. Desired Skills:* Bachelor?s Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master?s degree with a minimum of 3 years of relevant experience. Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics. Experience with executing raw material assay methodologies including spectroscopy, wet chemistry, and chromatography Experience working in a pharmaceutical testing environment Strong technical writing skills and the ability to effectively communicate with manufacturing, materials management, and qa staff. thirty About the Company: This is an exciting opportunity to join a major BioPharma and Vaccine company rapidly developing and commercializing novel vaccines including a vaccine for COVID-19.	San Diego, CA
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. * thirty 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
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. * 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
QC Lead, Empower/LIMS Administrator, R29353 null About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19.	Portsmouth, NH
Night Manufacturing Supervisor-GMP This is a key supervisory opportunity serving as a Manufacturing Supervisor with a top global leader in life sciences. You will be responsible for overseeing the production of therapeutic proteins (API) under current Good Manufacturing Practice (cGMP) conditions for the night shift. Your overall responsibilities will include: Planning and preparing for production, scheduling tasks, and assigning duties to operators to meet production schedule, assess production records, and meet release timelines to deliver quality product to customers Setting up, operating equipment, and monitoring production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations Reporting production in written and electronic documents in accordance with good documentation procedures (GDPs) Reviewing documentation (batch records, Standard Operating Procedures, Logbooks) for completeness, clarity, and accuracy while submitting edits to documents for revision. Desired Skills: Bachelor's degree in Life Science related discipline Good Manufacturing Practice (GMP) setting experience required Strong decision making abilities and critical thinking skills Previous start up experience supervising production processes About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19.	Portsmouth, NH
.NET Core Engineer, Healthcare Technology Solutions This is an exciting opportunity within a well funded, self sufficient, profitable San Diego based company with major fortune 500 clients in the high growth health and wellness industry. The company is on track for rapid growth due to increased client acquisition and competitive advantages in technologies. It's also an opportunity to work remotely in a team environment with other team members based in a modern San Diego HQ office. You will be responsible for designing, executing and delivering high quality web and mobile software products. The ideal candidate is a creative thinker and self-starter with a combination of expertise in Full-Stack .NET and modern Javascript UI/UX frameworks. This is an opportunity to build next generation products and applications which will directly impacts users' lives for the better by improving their health and wellness. Your roles and responsibilities will include: Building and maintaining reusable code libraries using the .NET Core framework. Developing modern User Interfaces with Javascript frameworks including VueJS, Angular and React. Maintaining and enhancing legacy ASP.NET Web Forms. Transitioning legacy software platform to modern .NET and Javascript frameworks. Optimizing applications and frameworks for maximum speed and scalability. Participating in technical questions in RFPs and customer engagements when required. Working with the development team to design architectural changes. Responding to clients requests for changes, maintenance, reports, queries and investigations. Serving as a subject matter expert, providing: guidelines, best practices and training to other individuals regarding web and mobile development, application and design. Formulating concepts and ideas for additional products, tools and services that can be provided in the digital space Troubleshooting execution challenges in complex projects (application, infrastructure, code quality, data and performance) and enable focused corrective actions to make the innovation successful Desired Skills: BS or MS degree in Computer Science or equivalent. 3+ years of development experience worknig with .NET Core, C# or ASP.NET Web Forms. UX / UI experience utilizing modern Javascript frameworks including VueJS, Angular and React. Experience working with RDBMS including Oracle and/or SQL databases. Experience working with version control systems including SVN, Git or Bitbucket. Expertise working with Scrum / Agile methodologies. Experience working on Healthcare, Medical Records or Wellness related applications a plus. Willingness to work directly with customers and product stakeholders (internal and external). Ability to effectively work successfully as a team player within a remote team environment. 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	Hartford, CT
Director of Sales, Healthcare Technology SaaS This is an exciting opportunity within a well funded, self sufficient, profitable local San Diego based Healthcare Technology SaaS 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 growing customer base, determining customer needs, proposing solutions, closing deals and developing long-term relationships. You will also liaise with cross-functional internal teams to ensure the timely and successful delivery of our solutions according to those customer needs. Your roles and responsibilities will also include. - Target, prospect and set up phone calls with new customers within Health Plan, Broker and Employer market segments - Initiate, establish and maintain strong, long-lasting customer relationships - Ability to convert opportunities generated through social media, online PPC ads and CRM software solutions. - Develop a trusted advisor relationship with key customer stakeholders and executive sponsors - Ensure the timely and successful delivery of technology solutions per customer needs - Be knowledgeable of the functionality and capabilities of the product solutions - Clearly communicate the progress of initiatives to internal and external stakeholders - Identify client upsell opportunities and collaborate with sales teams to grow revenue - Respond promptly and efficiently to client phone and email inquiries - Assist with high severity requests or issue escalations as needed - Aggressively follow up on sales leads; schedule discovery calls and live product demonstrations - Assist with portal and application testing as needed Desired Skills: - 5+ years of sales prospecting, sales leadership and sales closing track record of success - Should bring existing relationships with key stakeholders at regional health plans. - Proven track record of selling SaaS software solutions. - Well versed in hunting for prospects with use of various sales tools. - Experience with managing small sales teams. - Experience in delivering client-focused solutions based on customer needs - Proven ability to manage multiple projects at a time while maintaining strict attention to detail - Excellent listening and presentation skills - Excellent verbal and written communications skills - Ability to multitask and take on new tasks as assigned - BA/BS degree or equivalent - Health and wellness technology or administration experience a plus - Willingness to learn and an attitude of delivering high quality customer service About the Company: - Work at a technology company that is on the cutting edge of web and mobile-based products in Health and Wellness industries - Modern new office in San Diego with IdeaPaint walls, gourmet kitchen, occasional catered lunches, quality fresh ground coffee, and excellent snacks - Mac and Windows friendly environment - Flexible work schedules including some work-from-home days - 401K, medical / dental / vision healthcare coverage, and other benefits - Business casual environment - Unlimited performance based compensation - Participation in Company Stock Option Program	San Diego, CA
QA 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 testing high quality software solutions and testing software quality standards for all software products. 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 software functional testing within a SaaS environment. 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. Desired Skills: - 2-4 years experience working in a Software QA role, ideally working within a tech start-up, web SaaS, cloud-based environment or mobile app creation company. - Understanding of different testing methodologies (e.g., functional, destructive, regression). - Exposure to Agile development process with sprint planning and retrospectives. - Attention to detail for finding/reporting bugs and high communication skills. - Would be desirable to have previous tech support experience. - Experience creating effective test plans, test responses and BDD test cases. - Mobile testing exposure (iOS, Android) would be an advantage. - Ability to adapt to new priorities and challenges and willing to learn new technology. - Ability to work/communicate with different disciplines (tech/non-tech) as well as being able to co-ordinate with product owner & development team. - Ability to run manual testing, destructive testing with possibilities to do automation testing. - Development background in ASP.NET / C# with a good knowledge of .NET ecosystem knowledge would be an advantage. - thirty About the Company: - Work at a technology company that is on the cutting edge of web and mobile-based products in Health and Wellness industries - Modern new office in San Diego with IdeaPaint walls, gourmet kitchen, occasional catered lunches, quality fresh ground coffee, and excellent snacks - Mac and Windows friendly environment - Flexible work schedules including some work-from-home days - 401K, medical / dental / vision healthcare coverage, and other benefits - Business casual environment - Unlimited performance based compensation - Participation in Company Stock Option Program	San Diego, CA
Mgr. Medical Information null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Sr. Process Validation Engineer null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Sr. Bioprocess Engineer-Upstream null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Manager, Informatics null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Senior Clinical Programmer null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Director, Biostatistics null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Senior Scientist/Manager, CMC Documentation & Strategy null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Sr. Scientist/Engineer, Downstream Purification MSAT This is an exciting opportunity responsible for overseeing Downstream Purification Drug Substance Manufacturing Sciences & Technology (MS&T) related activities for the manufacturing of vaccine product candidates. This is an exciting opportunity to join a Maryland vaccine company rapidly developing, commercializing and manufacturing COVID-19 vaccines. Your responsibilities will include: * Leading MSAT projects relating to downstream purification manufacturing operations. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing technical 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. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Microbiology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments. * Strong Scientific and Engineering technical experience performing 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: 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
QC Analyst level 3 null About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Senior Scientist/Principal Scientist, Vaccine Drug Product Manufacturing This is an exciting opportunity responsible for leading scale up, technical transfer, and technical support of cGMP drug product manufacturing for COVID-19 vaccines. This is an exciting opportunity to join a Maryland vaccine company rapidly developing, commercializing and manufacturing COVID-19 vaccines. Your responsibilities will include: * Leading the scale-up, tech transfer and validation of sterile parenteral products and processes. * Providing advanced technical support for aseptic processing, lyophilization and related fill/finish Drug Product manufacturing operations. * Supporting technical aspects of commercial drug product manufacturing, including implementation of process improvements, troubleshooting, and technical investigations * Leading sterile facilities inspections and corresponding Pre-Approval Inspections. * Working cross-functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to optimize upstream and downstream related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Training staff on cGMP compliance, CMC regulations, FDA inspection readiness and writing/reviewing SOPs, batch records, process validation documents, and sections of regulatory filings. Desired Skills: * BS or MS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Technical expertise and knowledge involving aseptic processing, lyophilization, freeze drying, isolators, barriers and related fill/finish Drug Product technologies. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Supporting PAI (Pre-Approval Inspection) readiness activities. About the Company: The position is within a top BioPharma company that is rapidly growing its vaccine development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity to develop a promising pipeline of recombinant protein vaccine products. A comprehensive benefits package is offered with this position.	Gaithersburg, MD
Sr QC Stability Specialist, BioPharma Manufacturing This is an exciting opportunity responsible for overseeing all Quality Control Stability activities for late stage manufacturing of biologic vaccines. You will be charged with overseeing the following activities: * Overseeing Quality Control Stability Operations for late stage mammalian cell culture and biologic vaccines manufacturing. * 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. * 7+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific and Engineering expertise working in Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Hands-on expertise in QC testing, methods development, and characterization including biochemical, chromotographic, electrophoretic, ELISA, Western Blot, PCR, bioassays, and cell-based assays. * Expertise leading QC methods development, methods qualification, and methods validation activities. * Experience ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA audits & inspections. * Expertise working with or setting up Laboratory Information Systems (LIMS) for QC stability data. * Expertise working within cGMP compliance and providing GMP documentation. * thirty About the Company: 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
Tech Transfer Manager, Drug Substance Manufacturing This is an exciting opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related drug substance technology transfer and manufacturing activities for biologics vaccine manufacturing. You will be charged with overseeing the following activities: * Identifying, selecting and managing Contract Development (CDMO) and Contract Manufacturing Organizations (CMO) for process optimization, cGMP manufacturing and supply for Drug Substance Manufacturing in support of ongoing clinical programs. * Providing input on Drug Substance upstream mammalian cell culture process development strategies in shake flasks and stirred tank bioreactors. * Providing input on Drug Substance downstream purification process development strategies involving depth filtration, tangential flow filtration and column chromatography. * Overseeing CDMO process development through clinical and pre-commercial stages. * Preparing, reviewing and editing cGMP batch records, CMC regulatory, and Quality documents * Working with Quality teams to implement appropriate analytical methods and protocols. * Providing technical support and leadership for technology transfer and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates including media, buffers and cleaning solutions. Desired Skills: * BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience leading and managing tech transfer activities to CDMOs and CMOs. * Scientific and Engineering technical experience in upstream and downstream manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, stainless steel bioreactor operations, chromatography, filtration and recovery. * Experience leading projects relating to CMC filings, 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. * Avaiability to travel up to 50% domestically and internationally. 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
Tech Transfer Manager, Drug Product This is an exciting opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related drug product and fill/finish technology transfer and manufacturing activities for biologics manufacturing. You will be charged with overseeing the following activities: * Leading MSAT staff and projects relating to drug product manufacturing operations. * Providing technical leadership and subject matter expertise relating to drug product fill & finish related deviations, change control, process optimization, and technical troubleshooting. * Handling of complex and highly automated systems and overseeing all state-of-the-art equipment including formulation, aseptic liquid filling, pre-filled syringe lyophilization, and packaging apparatus. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead drug product fill & finish related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Serving as a technical/scientific Subject Matter Expert drug product fill & finish 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 engineering 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 in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 6-10+ 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. * Experience 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, Regulatory, Quality, and Engineering Services departments. * Strong Scientific and Engineering technical experience performing fill & finish manufacturing activities from formulation through packaging activities. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma. 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
Program Manager, Sr. 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. 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, Regulatory Affairs, Quality, Preclinical development, Clinical Development, alliance management or commercialization 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. * 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
Project Manager/Sr Project Manager-Oncology/Rare null 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.	Norton, MA
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
Senior Research Associate, Cell-Based Assays Senior Research Associate, Cell-Based Assays This is an exciting opportunity responsible for developing, qualifying and validating pre-clinical and clinical cell-based assays for vaccine development efforts. Its also an opportunity to apply Virology and Immunology expertise towards the development of late stage vaccine development programs. This is an exciting opportunity to join a leading CRO company rapidly developing and commercializing novel vaccines. Your responsibilities will include: * Leading the development, qualification and validation of cell-based assays including ELISA, ELISpot, neutralization assays and plaque assays. * Developing, optimizing, automating and troubleshooting a broad range of immunoassays and cell-based assays. * Identifying and proposing new assay technologies and lab automation solutions to achieve efficient workflows. * Overseeing sample management, routine laboratory testing and clinical laboratory testing operations. * Serving as a subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results. * Investigating and researching current science, new findings and new scientific techniques and lab methods. * Applying Virology and Immunology concepts for vaccine research and development efforts against infectious diseases. Desired Skills: * BS or MS in Immunology, Virology, Microbiology, Biology, Biochemistry, Analytical Chemistry, Molecular Biology, Microbiology or related Scientific field. * 3+ years of BioPharma, BioPharmaceutical, Pharmaceutical, Vaccine or Biotechnology industry experience. * Hands on expertise and proficiency working with cell-based assays and immunoassays. * Expertise working with ELISA, ELISpot, neutralization assays and plaque assays. * Extensive knowledge of cGLP compliance, ICH guidelines and CFR regulations which govern laboratory processes. * Thorough knowledge and understanding of Virology and Immunology concepts for vaccine development efforts against infectious diseases. 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.	Redwood City, CA
Sr Project Manager, Lab Services This is a key leadership opportunity serving as Sr. Project Manager, Data Science Solutions. You will be responsible for leading client management and operational execution of technology-enabled data services in a client-facing role. You will be responsible for coordinating services with vendors or third part organizations including CROs and Labs. Your overall responsibilities will include: Planning, organizing, and leading projects with technical experts Creating and maintaining study documentation for data solutions Developing, implementing, and improving business processes to enable effective, efficient delivery services and develop and implement dashboards, monitor performance and report on project status Coordinating and communicating with team members across disparate technical and business backgrounds such as R&D, Marketing, Sales, Manufacturing, Executive Management, Quality Assurance and Regulatory Affairs, while building and managing timelines and budgets Desired Skills: Master's or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology, Computational Biology, Bioinformatics or related field 3 years of experience in data management, life science services, project management, or related field Experience with clinical data management or laboratory data management Understanding of the scientific or data aspects of cellular, molecular or biochemical assays such as flow cytometry, next-generation sequencing, MSD, Luminex, NanoString, ICH, PK or immunogenicity assays MS Project or Project Insight 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.
Director, Manufacturing Operations, Complex Food Products This is a stellar growth opportunity within a premier brand name complex nutritional food products company. You will be responsible for leading a combination of liquid and powder food processing and manufacturing operations and improvement initiatives for the production of of brand name complex food products. Your hands on responsibilities will include: * Serving as the site Operations and Manufacturing head of a 350+ employee operation among 2 plants manufacturing liquid and powder dairy food products. * Driving Operational Excellence initiatives for increasing manufacturing capacities for liquid and powder dairy food processing. * Managing manufacturing and production staff across multiple in a 24/7 production environment. * Leading Engineering staff driving continuous improvement processes utilizing Lean Manufacturing, Six Sigma, and Kaizen techniques. * Managing production processes utilizing spray dryers, liquid processing, hydrolyzed protein processing, and high speed packaging technologies. * Driving and leading OEE's, plant efficiency, productivity, and yield improvement projects to achieve optimal plant capacities by implementing Six Sigma, Lean Manufacturing, and other continuous improvement initiatives. * Providing strategic engineering insight to daily manufacturing process and packaging operations by offering solutions to complex manufacturing issues. * Working with leadership teams and external teams including Quality, Marketing, Supply Chain, Procurement, and Logistics departments to implement capital improvement and equipment upgrade projects. Desired Skills: * BS degree in Chemical Engineering, Mechanical Engineering, Food Science or related field. MBA a plus. * Exceptional management and strategic leadership experiences from within a major food, pharmaceutical or nutritional products manufacturing site. * 10+ years of Dairy, Food Processing, or Nutritional Products industry experience. * Food, Dairy, or Beverage Manufacturing and Production experience. Experience working with liquids, milk, spray dried dairy, spray dry milk, powders, or nutritional related products a plus. * Exceptional Project Management, Project Leadership, Process Improvement, and Capital Project Management experience. * Process Improvement experience implementing Continuous Improvement, Lean Manufacturing, or 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 documentation & SOPs. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Evansville, IN
QA Plant Hygienist, Infant Formula Manufacturing This is a stellar opportunity responsible for developing and leading a broad set of emerging plant sanitation, hygiene, and food safety initiatives for successful complex food product manufacturing. As QA Plant Hygienist, Nutritional Foods Manufacturing, your overall responsibilities will include: * Designing and implementing plant wide sanitation, hygiene, and food safety initiatives adhering to a wide variety of regulatory standards including FDA, cGMP, OSHA, and HAACP. * Implement and maintain the plant master sanitation program. * Leading internal plant sanitation and food safety initiatives to ensure internal departments including Quality Control, Quality Assurance, Production, Packaging, Manufacturing, Warehouse, Distribution, Procurement, and Research & Development departments operate within FDA, cGMP, OSHA and HAACP Compliance. * Leading continuous improvement initiatives to ensure supply chain activities adhere to plant wide sanitation, hygene, and food safety programs. * Designing and implementing food safety initiatives adhering to a wide variety of potential contaminants including pesticides, Mycotoxins by mold, chemical physical contaminants, and agricultural food chain contaminants. Desired Skills: * 5+ years of food or nutritional industry food safety, sanitation or compliance experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Food Safety, Nutrition, Food Science, Biology or related life sciences field preferred. * Familiarity with CIP (Clean in Place) and SIP (Steam in Place) procedures. * Familiarity and understanding of common and emerging supply chain and agricultural contaminants for complex food or nutritional food manufacturing. * Microbiology background and experience with familiarity and understanding of common Food Safety laboratory testing procedures. * Experience ensuring HAACP, cGMP, FDA and 21 CFR Part 11 compliance. thirty About the Company:* This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Zeeland, MI
Sr. Project Engineer, Complex Nutritional Foods Manufacturing This is a stellar opportunity within an established, thriving and growing complex food production company! You will be responsible for leading plant-wide processing and packaging related engineering projects for the successful manufacturing of brand name complex food products. Your hands on responsibilities will also include: * Overseeing projects including new construction, equipment upgrades, equipment installations, and entire manufacturing line installations. * Leading $10-20 M capital projects and process improvements involving food production and packaging equipment including blending systems, mixing tanks, steam injectors, spray dryers, liquid processing tanks, conveyors, and palletizers. * Leading and designing project budgets, schedules, construction, commissioning, and project take-over activities. * Managing project costs, cost proposals, project budgets, and capital budgets. * Leading and managing cengineers, contractors, and external vendors. * Providing cGMP and GMP documentation activities, writing SOPs, and developing PFD and P&ID, equipment and piping layout, and process and equipment specifications for bids. Desired Skills: * BS or MS degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering or related Engineering field. * Over 5 years of Food Processing industry experience. * Exceptional Project Management, Project Leadership, Process Improvement, and Capital Project Management experience. * Engineering expertise working with manufacturing facilities, utilities, HVAC, and electrical systems. * Process Improvement experience implementing Six Sigma methodologies involving Process Mapping, CTQ, Root Cause Analysis, Control Charts and Statistical Process Control (SPC). Six Sigma Green Belt or Six Sigma Black Belt a plus. * Expertise working within cGMP, FDA, HACCP & OSHA compliance and providing appropriate engineering documentation & SOPs. * PMP Certification a plus. thirty About the Company:* This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Evansville, IN
SBUS PBM/Strategy/Payer Engagement (Director to VP) null 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
CDO Advanced Technology Group null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Glendora, CA
CDO Formulation Development Scientist null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Glendora, CA
CDO - DSP Specialist null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Glendora, CA
CDO Analytical Method Development Scientist null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Glendora, CA
Facility Quality Manager null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Los Angeles, CA
Lead/Principal Scientist, DS3 MSAT Team, Analytical Group null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Los Angeles, 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. * thirty About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Los Angeles, CA
CDO Technical Expert null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Garden Grove, CA
CRO Discovery Project Leader null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com
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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Seattle, WA
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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Los Angeles, CA
Regulatory Affairs (SF or Korea) null About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Glendora, CA
Sr Director/VP, BioPharma Site Quality Assurance This is a stellar opportunity responsible for leading a broad set of company wide cGMP Quality Assurance, Quality Compliance, Regulatory Affairs, 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 expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity. Your roles and responsibility will include: * Leading the cGMP Quality Compliance and Risk Management team overseeing Internal Audits, External Audits and Regulatory Inspection activities. * Overseeing staff performing External Audits, Internal Audits, Inspections, Vendor/Supplier Qualification and Management, Product Complaints, Deviations/CAPA, Document/Change Control and Training. * Ensuring PAI readiness activities, all regulatory inspections and any other audits. * Overseeing Quality Compliance, Risk Mitigation and Risk Management activities including Compliance Risk Assessment as well as Process Compliance Risk Registry, Remediation and Tracking. * Leading Quality Systems Management including the Quality Compliance, in-house compliance systems, and document control systems. * Leading Supplier Quality teams 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. * Hosting regulatory inspections, leading inspection readiness activities, and leading Pre-Approval Inspections (PAI). * Working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA. Desired Skills: * 12+ 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 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. * Quality leadership overseeing cGMP Quality Compliance, Risk Management, Quality Systems Management, Supplier Quality and Site Quality Assurance activities capacities. * Experience hosting and leading global regulatory audits and regulatory inspections. * Strong experience ensuring cGMP compliance and working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA. * thirty About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Philadelphia, PA
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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Southern MD Facility, MD
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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Seattle, WA
VP/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 company and plant expansions. This is a unique growth opportunity within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation working with major Global BioPharma companies. You will be charged with overseeing the following activities: * 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. * 15+ 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: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	Hanscom AFB, MA
Sr. Director/Director, MSAT Biologics, Expat In South Korea This is an exciting international expat opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related upstream and downstream activities for large scale commercial recombinant protein manufacturing. This position is immediately available due to company and plant expansions. This is a unique growth opportunity within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation working with major Global BioPharma companies. You will be charged with overseeing the following activities: * Leading MSAT staff and projects relating to upstream cell culture/fermentation and downstream protein purification manufacturing operations. * Managing late stage development activities including process characterization studies, process validation studies, scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Providing technical leadership and subject matter expertise relating to downstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * 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. * Working directly with internal manufacturing sites and external Contract Manufacturing Organizations to ensure supply continuity and manufacturing productivity. * Working cross functinally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to optimize upstream and downstream 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/fermentation activities and downstream purification activities ranging from vial thaw, inoculum, media development, media optimization, cell line development, stainless steel bioreactor operations, chromatography, filtration and recovery. * Training staff on cGMP compliance, CMC regulations, FDA inspection readiness and writing/reviewing SOPs, batch records, process validation documents, and sections of regulatory filings. Desired Skills: * MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * 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. * Experience overseeing technology transfer activities and supporting operations with 3rd party CMOs as well as internal company manufacturing sites. * Strong Scientific and Engineering technical experience performing upstream and downstream manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, stainless steel bioreactor operations, chromatography, filtration and recovery. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma. About the Company: This is an amazing Expat opportunity working within a the World's Largest Biologics CMO near ICN airport and Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position: * Company paid housing in South Korea. * 3 weeks of vacation time. * International school tuition paid for children. The school is exceptional! www.chadwickinternational.org * Full Korean healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea's tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School - www.songdo.com	San Francisco, CA
Director, Bioanalytical Development, Monoclonal Antibody 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.	Los Angeles, CA
Lead Scientist, Immunoassay Development This is an exciting new opportunity within an established and expanding Southern California based BioPharma company. You will be responsible for driving analytical development activities utilizing state-of-the-art bioassays, immunoassays, and cell based assays for the development of novel Monoclonal Antibody therapeutics. Your overall responsibilities will also include: * Driving the development, troubleshooting and validation of state-of-the-art bioassays, immunoassays, and cell based assays for analytical methods implementation, validation, qualification, technology transfer, and protein characterization activities. * Driving bioassay development efforts for cell based assays, functional assays and immunoassays including ligand binding immunoassays, immunogenicity assays, ELISA, DELFIA, TRF and MSD immunoassays. * Developing and leading biological characterization strategies for monoclonal antibody therapeutics from R&D stages, IND stages through to BLA and commercialization. * Leading assay optimization, validation and transfer of validated bioassay methods to CROs and commercial QC laboratories. * Driving the scientific and technical development of Monoclonal Antibody therapeutics. * Applying Design of Experiments to assay optimization and qualification. Desired Skills: * Ph.D. or MS in Pharmaceutics, Pharmaceutical Technologies, Formulations, Biochemistry, Chemistry or related Scientific field. * 3+ years of Biotechnology or BioPharmaceutical industry experience. * Experience in the design, development, optimization, qualification, and transfer of cell based assays, functional assays and immunoassays including ligand binding immunoassays, immunogenicity assays, ELISA, DELFIA, TRF and MSD immunoassays. * Drug Development experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired. * Expertise working with software and data analysis packages including SoftMax Pro, WinNonLin, GraphPad Prism or JMP. * Scientific & Technical leadership experience developing Monoclonal Antibody therapeutics. * Experience applying Design of Experiments to assay optimization and qualification. * 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.	Los Angeles, CA
Principal/Manager of Biostatistics null 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.	San Diego, CA
Scientist, Analytical Methods Development, Monoclonal Antibody Therapeutics This is an exciting new opportunity to join and startup a new lab within an established and expanding Southern California based BioPharma company. You will be responsible for driving analytical development activities including HPLC and Capillary Electrophoresis based methods for the development of novel Monoclonal Antibody therapeutics. Your overall responsibilities will also include: * Developing analytical methods with chromatography based HPLC and UPLC methods for use in release and stability testing of biotherapeutic clinical trial materials. * Developing, transferring and troubleshooting capillary electrophoresis methods. * Assisting with the installation, set up, troubleshooting and routine maintenance of new laboratory equipment including Agilent, Waters and Sciex HPLC, UPLC and Capillary Electrophoresis equipment. * Providing expertise in the analytical characterizing biopharmaceutical products utilizing HPLC, UPLC, Capillary Electropheresis, SEC, CEX, RP, HIC and other modern protein separation techniques. * Driving the scientific and technical development of Monoclonal Antibody therapeutics. * Applying Design of Experiments to assay optimization and qualification. Desired Skills: * MS or Ph.D. in Pharmaceutics, Pharmaceutical Technologies, Formulations, Biochemistry, Chemistry or related Scientific field. * 3+ years of Biotechnology or BioPharmaceutical industry experience. * Experience in the design, development, optimization, qualification, and transfer of chromatography-based assays including SEC, CEX, RP, HIC and normal phase for biologics. * Familiarity and expertise in the design, development, optimization, qualification and transfer of Capillary Electrophoresis based methods including SDS-CGE and icIEF for biologics. * Expertise working with Waters Empower or Sciex 32Karat software packages a plus. * Scientific & Technical leadership experience developing Monoclonal Antibody therapeutics. * Experience applying Design of Experiments to assay optimization and qualification. * Experience troubleshooting and performing routine maintenance of new laboratory equipment including Agilent, Waters and Sciex systems. * thirty Please note that due to current COVID-19 safety conditions, this position is located within the Los Angeles area lab on a half schedule. It is a full time position requiring work on-site 3-4 days a week. 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.	Altadena, CA