- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... ( CMC ) activities related to biologic product development at Formation...role in scaling our biologics capabilities in partnership with technical , quality, and regulatory leaders.Responsibilities Strategic Leadership Develop and… more
- Merck & Co. (Rahway, NJ)
- …Division / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Eli Lilly and Company (Indianapolis, IN)
- …Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical knowledge and regulatory science expertise to drive regulatory CMC ... world. The Senior Advisor/ Director Post approval scientist in...the lifecycle of the assigned product(s). Key responsibilities: Deep technical knowledge of solid oral products CMC … more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or… more
- Merck & Co. (Rahway, NJ)
- …to communicate program progress, issues, and mitigation plans to the senior management.Innovative mind-set demonstrated by technical accomplishments, external ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- nChroma Bio (Boston, MA)
- …and breakthrough medicines. ABOUT THE ROLE nChroma Bio is seeking a Senior Director , Analytical Development/Quality Control to drive the strategic development ... candidate's ability to represent the AD/QC function in Regulatory CMC meetings and drafting the Module 3/IB documents is...stability programs at CDMOs and CTLs. *Work with the technical operations team to ensure the development of robust… more
- Vaxcyte (San Carlos, CA)
- …equality and clarity across communications and decision making. Summary: The Director , Process Validation and Risk Management has the accountability for: Commercial ... end -to-end processes Identification, assessment, and mitigation of operational, technical , and regulatory risks within the end-to-end manufacturing processes In… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical Lexington, MA Hybrid ... on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages ... strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous...Excellence - Expertise** + Recognized as a deep scientific technical expert in CMC drug development and/or… more
