- Merck & Co. (Rahway, NJ)
- …with cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Eisai, Inc (Exton, PA)
- …Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other ... Control , Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established and emerging… more
- Merck & Co. (Rahway, NJ)
- …Development, Estimation and Planning, GMP Compliance, Management Process, Manufacturing Quality Control , Medical Supply Management, Medicinal Chemistry, ... and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics , vaccine) Drug Product development and Good Manufacturing Practice (GMP)… more
- Merck & Co. (Rahway, NJ)
- …scientific methodology, we collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Company's Research ... scientific role tasked with working closely with the group Director to define group strategy and to lead a...chemistry, and lab informatics disciplines to enable development of biologics pipeline.We are looking for a team player with… more
- Merck & Co. (Durham, NC)
- …substance and drug product, including product inspection, warehouse, utilities, and quality control laboratories.The Specialist, Operations will be responsible ... making accessible our company's next generation of Vaccines and Biologics . To this end, we strive to create an...x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a new… more
- Merck (Rahway, NJ)
- …with cross-functional development teams to enable pipeline decisions. The Executive Director , Biologics Analytical Research and Development (B-AR&D) is ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** **Job Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and ... hire new talent. + Accountable for: + Defining critical quality attributes (CQAs) across the late-phase biologics ...Molecular analysis. + Subject matter expert in establishing comprehensive control strategies for biologics products. + Well… more
- Takeda Pharmaceuticals (Lexington, MA)
- …technical assessments and risk analyses to inform program strategies. + Drive quality control and regulatory strategies for late-stage development, including ... in chromatographic and electrophoretic techniques (HPLC, CE-SDS, icIEF, etc) and biologics analytical control strategies. + Solid knowledge of late-stage… more
- Catalent Pharma Solutions (Madison, WI)
- ** Director , Quality Control ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... and life-saving treatments for patients annually. Working for Catalent Biologics is an opportunity to join an entrepreneurial team....heart and lung diseases as well as Alzheimer's. The Director of Quality Control is… more
- BeOne Medicines (Emeryville, CA)
- …biologics regulatory CMC overarching strategies for alignment, * Lead or/and oversee biologics CMC change control regulatory CMC impact assessment and ensure ... is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC… more
- AbbVie (Worcester, MA)
- …validation & technical protocols & reports, lab investigations, manufacturing records & quality control data. + Establish & execute plans & commitments ... team including contributors in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control ,… more
- Charles River Laboratories (Rockville, MD)
- …FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies * Experience preferred with CDMO business ... met successfully. * Provide leadership to and ensure necessary Quality oversight to areas within span of control...experience * Minimum 8 years of experience in a biologics , pharmaceutical, medical device, or related industry. 10 years… more
- Charles River Laboratories (Memphis, TN)
- …is not limited to: sterility assurance, environmental monitoring of the faciity, quality control microbial testing, utility monitoring, and site contamination ... Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units to ensure contamination control and sterility… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and a MS in a relevant field of study.** + **Extensive background in Biologics Operations (eg Manufacturing, Quality Control , Quality Assurance)** ... aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director - QA Compliance, will report to the Director of Supplier… more
- Charles River Laboratories (Memphis, TN)
- …for delivery on the project including Process Sciences, Manufacturing Sciences & Technologies, Quality Control , Quality Assurance, Supply Chain to ensuring ... you can feel passionate about. **Job Summary** Reporting to the Site Director , the Associate Director , Biomanufacturing Operations is responsible for managing… more
- Bristol Myers Squibb (Devens, MA)
- …is meaningful, consider joining our diverse team! Reporting to the Executive Director , Business Insights and Technology (BI&T)- BioPharma Operating Units, the Sr. ... Director , BI&T, Devens Digital Plant and Site BI&T Lead...BI&T Lead will be directly accountable to the US Biologics Leader and Devens Campus Leader and will be… more
- AbbVie (Waltham, MA)
- …capable of performing as leaders, team members and individuals. + Strong quality assurance / control , manufacturing, laboratory, technical support, regulatory, ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Responsible for quality of assigned products which may include small molecule pharmaceuticals… more
- Teva Pharmaceuticals (West Chester, PA)
- …biosimilars, small molecule specialty medicines, generics and over-the-counter therapies. The Associate Director at Bioassay Department of Biologics CMC leads a ... Associate Director , Binding and Cell-Based Bioassay - Onsite (West...potency methods to support the release and characterization of biologics in conformance with cGxPs. + Lead and support… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Associate Director , Global Quality and Compliance Excellence uses advanced subject ... problem-solving skills, and demonstrate strong interpersonal skills. + Strong quality assurance / control , manufacturing, laboratory, technical support,… more
- University of Southern California (Los Angeles, CA)
- …for product testing. + Lead technology transfer to cGMP manufacturing and quality control , ensuring efficient scaling and implementation. Develop and review ... cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP-Associate- Director --Process-Development\_REQ20159691-1/apply) Keck… more
