- Lilly (Boston, MA)
- …for people around the world. **Job Summary** The Director/Senior Director, CMC , Drug Product Development will lead formulation development activities across multiple ... CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development… more
- Takeda Pharmaceuticals (Boston, MA)
- …combination products, while bringing the current products to today's standards. + Represent CMC and GRA on key governance committees and play a critical role in ... driving the organization towards innovative approaches for adoption and registration of new technologies/molecules in the pipeline, such as small molecules, synthetic peptides and oligonucleotides - novel and delivery approaches that are unprecedented. + Lead… more
- Sanofi Group (Cambridge, MA)
- …a principal scientist. The group is part of the synthetic platform within Global CMC Development with focus on small molecules that is striving to become an industry ... projects and studies + Represent the analytical group in late development CMC projects + Ensure timely completion of analytical deliverables (eg, draggability… more
- Takeda Pharmaceuticals (Boston, MA)
- …to increase business performance, organizational efficiency while increase speed for CMC deliverables, including AI-forward projects and mindset. + Partner with PS, ... lead enterprise-wide transformation initiatives, with a focus on increasing CMC productivity of a minimum 5% per year and...productivity of a minimum 5% per year and ensure CMC costs is financially sustainable with increasing R&D portfolio.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the successful candidate will span across both Chemicals, Manufacturing, and Controls ( CMC ) and focused areas of drug discovery with specific support to preclinical ... and validation. For more information on CMC , click here (https://www.mckinsey.com/industries/life-sciences/our-insights/out-of-the-shadows-a-brighter-future-for-pharma-technical-development) , here… more
- Bristol Myers Squibb (Devens, MA)
- …commercial products. This role is responsible for developing and executing the CMC strategy for assigned products, managing key technical risks, and ensuring ... alignment with stakeholders. As a key member of the CMC and Global Operations (GO) Team, they will support...integrated technical roadmap for Key Vector assets. + Develop CMC technical strategy for life cycle or pipeline programs;… more
- Takeda Pharmaceuticals (Boston, MA)
- …collaboration during troubleshooting and optimization. + Author and/or review key CMC and quality deliverables, such as: + protocols, validation reports, methods, ... investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant drug product)… more
- Sumitomo Pharma (Boston, MA)
- …strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs ... collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports, investigator… more
- Takeda Pharmaceuticals (Lexington, MA)
- …strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. Through your deep product and process ... understanding you will shape CMC and program strategy and ensure robust control strategies...for assigned products. + Lead preparation and review of CMC dossier sections related to product quality, characterization and… more
- Sanofi Group (Waltham, MA)
- …an integrated end-to-end mRNA platform that brings together R&D, digital capabilities, and CMC expertise under one roof. Bring your ambition and optimism and join us ... preclinical and clinical biomarker assays, + Support the overall CMC DS & DP group by analyzing samples via...DNA/RNA isolation etc. + Support strategic writing of the CMC section of the regulatory dossier **People:** + Is… more