- 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
- 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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
- Sanofi Group (Waltham, MA)
- …Statistician- Vaccines **Location:** Waltham, MA **About the Job** As an experienced mRNA CMC Principal Statistician, you will lead and coordinate the team ... CoE Data and Computational Science team in platform and project technical teams as statistical CMC subject...and participates in the drafting of patent filings + Lead preparation and publication of scientific papers and congress… more
- WuXi AppTec (Natick, MA)
- …a WuXi AppTec Company, has an exciting opportunity for a **Manager/Senior Manager, CMC Project Management.** This position will be responsible for managing DS ... and DP projects within STA. The position will lead the orderly progression of projects from the proposal...orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team,… more
- Sanofi Group (Waltham, MA)
- …functional areas to deliver on CMC milestones while adhering to broad project timelines + Lead and participate in technical team discussions + ... **Job Title:** Senior Scientist, GMU CMC Drug Product Development **Location** : Waltham, MA **About the Job** Are you ready to shape the future of medicine? The… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytics towards enhancing portfolio prioritization, decision-making and delivering on business objectives. Lead the R&D CMC efforts for leveraging digital and ... towards enhancing portfolio prioritization, decision-making and delivering on business objectives. + Lead the CMC efforts for leveraging digital and AI tools… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Operations Lead , Digital R&D Portfolio and Project Analytics **Location** : Morristown, NJ or Cambridge, MA **About the Job** At Sanofi, we're ... right time, for the right decision. As the **Operations Lead , Digital R and D Portfolio and Project...good understanding of Pharma R&D reporting analytics, at portfolio, project or functional level (Clinical Operations, CMC ,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …+ Build, lead and mentor the regulatory team and provide project teams with the strategic regulatory guidance to expedite product development, registration and ... will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for...cell transplant. In this position you will build and lead a cell medicine regulatory affairs team and provide… more
- Sanofi Group (Cambridge, MA)
- **Global Project Head -AATD* SAR447537** **Development** The Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic ... Area Head to provide leadership, supervision, and coordination within the Global Project Team (GPT). The GPH position requires achieving results through others and… more