- Merck & Co. (Rahway, NJ)
- …Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of...development.The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 10-15… more
- Eisai, Inc (Exton, PA)
- …Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Bristol-Myers Squibb Company (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. Summary The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops ... and/or development/manufacturing of radiopharmaceuticals is required. Recognized as a CMC expert, radiopharmaceuticals and/or biologics , with an ability… more
- EPM Scientific (Rockville, MD)
- …years of experience in biopharmaceutical process development, MSAT, or CMC roles. Extensive experience with commercial-scale cleaning validation and contamination ... Proven expertise in large-scale stainless steel bioprocesses. Experience supporting DS manufacturing and cross-functional technical problem-solving. Must have biologics … more
- AbbVie (Worcester, MA)
- …for AI and digital strategy, influencing and driving end-to-end digital integration within Biologics CMC . This leader will collaborate closely with IT partners ... and tools (such as TensorFlow, PyTorch, or similar) that are relevant to biologics CMC workflows. + Demonstrated ability to leverage AI and ML techniques for … more
- Merck (Rahway, NJ)
- …Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... Division/our Research & Development Division) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of...The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 10-15… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced ... drive the implementation of evolving scientific technologies to support late-stage biologics programs. With a deep focus on separation-based techniques (eg, U/HPLC,… more
- Merck (Rahway, NJ)
- …of regulatory submissions. Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in ... expertise in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to… more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …+ Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics , Biosimilars, and Small ... Description: Subject matter expert in the area of Biologics . Promotes and develops initiatives to continually improve working relationships within and across… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology ... and modeling & simulation strategies for small molecules and biologics assets in the company portfolio. She/He will provide clinical pharmacology & pharmacometric… more
- AbbVie (North Chicago, IL)
- …Quality Assurance strategy and implements agreed strategy to support pharmaceuticals, Biologics , Neurotoxin and/or Gene Therapy produced at AbbVie plants as well ... strategic programs; including Brand Teams, New Product Introductions, Product Transfers, CMC , Global Strategic Sourcing, Due Diligence, Site Selection, and Approvals… more
- Sanofi Group (Framingham, MA)
- …Lead, reports to the Head of AST and is based in Framingham, MA. **Analytical Lead/ Associate Director will:** + Serve as the primary contact for assigned product ... + Analytical Lead will serve as a member of CMC /Technical Product Team(s) for a product or a portfolio...execution of analytical activities for late stage and commercial biologics . + Development and manufacture of biopharmaceuticals is one… more
- University of Maryland, Baltimore (Baltimore, MD)
- … regulatory science, including: Chemistry, Manufacturing, and Controls ( CMC ); Clinical Research; Pharmacovigilance; Phase IV Research (eg, Pharmacoepidemiology); ... and Drug and Biologics Discovery. Additionally, responsibilities include a Certificate in regulatory...Pharmaceutical Sciences with teaching responsibility to the Graduate Program Director and Associate Dean for Graduate Programs.… more
