- Organon & Co. (Jersey City, NJ)
- …regulatory strategies. + Prepare and review information required for development of regulatory CMC dossiers for commercial products. + Provide input to global ... milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as… more
- Bristol Myers Squibb (Summit, NJ)
- …for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will collaborate across BMS sites with Analytical, ... questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will collaborate across BMS...and process development principles. + Experienced in building the CMC dossier for regulatory submissions as an… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Merck (Rahway, NJ)
- …Research and Development (ARD) at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation & ... closely with other analytical groups in ARD , Global Quality and Regulatory Affairs- CMC to ensure that validated methods are appropriately transferred from our… more
- Merck (Rahway, NJ)
- …Description:** **Biologics Process Research and Development (R&D) Downstream Principal Scientist ** Our Scientists are our Inventors. Using innovative thinking, ... to join Biologics Process Research & Development (BPR&D) as a Principal Scientist . Biologics Process Research & Development (BPR&D) within our Company's Research… more