- Astrix Technology (Minneapolis, MN)
- …formulation of small molecules, peptides, and antibodies. + Prepare and manage CMC documentation to support regulatory filings and clinical/commercial readiness. ... ** Director of Pharmaceutical Development** Science & Research Minneapolis...deviation investigations and ensure full compliance with GMP and regulatory standards. **Qualifications** + Ph.D. in Chemistry, Biochemistry, or… more
- Merck (West Point, PA)
- …BLAs.- The successful candidate will be responsible for strategic partnering with CMC development, Regulatory , Quality, and our partners in commercialization and ... and ensure safety and quality of our products. The Director of Vaccines Potency in Analytical Research & Development...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- US Tech Solutions (Holly Springs, NC)
- …new Drug Substance production facility. Responsible for also being able to enable CMC Regulatory file drafting and support, commissioning and qualification of ... Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ), CMC Regulatory file drafting and support, commissioning and… more
- Catalent Pharma Solutions (Kansas City, MO)
- ** Director , Quality, BioAnalytical** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, ... stand-alone and integrated biologics projects. Catalent Pharma Solutions is hiring a Director of Quality who is responsible for setting the strategic direction,… more
- Amgen (Cambridge, MA)
- …Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's ... leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team… more
- BeOne Medicines (Emeryville, CA)
- …our Research, Supply Production and Financial Analytics Initiatives. The Associate Director Research, Supply Production and Financial Analytics, Data Insights is ... tools for early discovery and translational research, supply readiness, CMC , cross-functional resource utilization, vendor performance and cost scenario modeling… more
- Lilly (Indianapolis, IN)
- …lifecycle of an asset ranging from the discovery/development interface through regulatory submission and post-approval changes. We work to improve patient outcomes ... saving therapeutics. **Role Overview:** We are seeking a veteran and visionary Sr. Director of Early Phase Chemistry to join our leadership team. This individual… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …four core domains: Global Health Integrated Development Expertise (GHIDE), Regulatory Affairs, Decision, Analyze, Communicate (DAC), and Chemistry, Manufacturing & ... Controls ( CMC ). IDev plays a critical role in advancing the...our product development investments are guided by robust data, regulatory insight, and operational excellence. Please note that the… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... with Non-Interventional Clinical Trials in a CRO setting in an Oversight Director /Portfolio Lead Role** + **RFP/Bid Defense Experience** **(You MUST show the above… more
- Sanofi Group (Framingham, MA)
- **Job Title:** GRA Device Lead (Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the future ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more