- Insmed Incorporated (NJ)
- …patients, for each other, and for the future of science, we're in. Are you?About the Role:The Sr . Director CMC QA will lead QA CMC oversight for drug ... every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Director of Toxicology as part of the Clinical Development … more
- Insmed Incorporated (NJ)
- …every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, ... personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes… more
- Formation Bio (New York, NY)
- …patent and IP portfolio, where you will work closely with our business development , legal, clinical, CMC , and data/engineering teams to on-board products with ... features Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development ,… more
- BeOne Medicines (Emeryville, CA)
- As Director of R&D Data Enablement / Data Products, you will lead the strategy and execution of building and scaling R&D data foundations and data products that ... internally defined ontologies / standards) embedding FAIR data principles. **Data Product Development ** + Build a portfolio of high-value data products that address… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **:** The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving ... guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations manages… more
- Boehringer Ingelheim (Ridgefield, CT)
- …leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director / Senior Associate Director ... an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at our Ridgefield, CT… more
- Amgen (Washington, DC)
- …modeling for CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, ... CMC data, spanning drug substance, drug product, and delivery device development . As Director , CMC Modeling & Advanced Statistics, you will: + Provide… more
- Danaher Corporation (Fargo, ND)
- …management of already established contracts and project/program execution. This position reports to the Director of Drug Product CMC and is part of the Drug ... of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation… more
