- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Lead **Location** : Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed up ... be critical in helping our teams accelerate progress. Global CMC Project Management is a CMC...with agility & strategic excellence. Our mission is to lead projects of the Sanofi R&D pharma portfolio from… more
- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA, Waltham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... be critical in helping our teams accelerate progress. The CMC Project Manager is a key contributor...feasibility and optimization with Functions representatives and communicate to CMC team + Lead risks assessment &… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** GRA CMC Lead **Location** : Swiftwater, PA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on to ... of GRA. + Provide leadership, guidance, and coordination to project teams of GRA CMC professionals in...and coordination to project teams of GRA CMC professionals in delivering specific development and marketed product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead . Assigned products include ... regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares and...within a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… more
- Gilead Sciences, Inc. (Foster City, CA)
- …into Pharmaceutical Development & Manufacturing (PDM) Project teams. **JOB DESCRIPTION** + Lead CMC regulatory strategy for a single or multiple products. + ... Regulatory Affairs, PDM, and other functional groups across Gilead. + Lead CMC strategies, assess risks, and develop contingency plans, including major, complex… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... to the cross-functional team in conjunction with global regulatory lead (s). + Prepare, coordinate and/or review all CMC and GMP related documents for submission… more
- Lilly (Indianapolis, IN)
- …Applications, post-approval supplements/ variations and responses to questions. **Oversight of CMC Project Deliverables** + Ensures appropriate definition and ... qualified for the work assigned to them and the project responsibilities associated with their position. + Ensures that...external environment. + Utilizes scientific and regulatory knowledge to lead preparation, review, and finalization of CMC … more
- Gilead Sciences, Inc. (Washington, DC)
- …Join Gilead and help create possible, together. **Job Description** The Director, CMC Regulatory Affairs Policy, Advisory and Intelligence is part of a team ... and advocating policy positions (internally and externally) in the CMC regulatory sphere. The role will be focused on...marketing applications. They will be accountable for consulting with project teams on the implementation of ICH and other… more
- Vera Therapeutics (Brisbane, CA)
- …as a subject matter expert and lead for all aspects of lead drug candidate development, including CMC developability, cell line development, process ... to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion...relevant sections for regulatory submissions. * Participate and represent CMC Process Development in project teams. *… more
- AbbVie (South San Francisco, CA)
- …deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an ... Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long… more