- Teva Pharmaceuticals (Parsippany, NJ)
- …and lifecycle management, translating product strategy into operational execution and representing Operations/ CMC on the global product team. As a key driver of ... Responsibilities include, but are not limited to: + Lead cross-functional Operations/ CMC teams for assigned innovative products throughout their lifecycle (from… more
- AbbVie (Irvine, CA)
- …for a comprehensive understanding of the product structure-function relationship. + Lead CMC analytical development with in-depth knowledge of a broad range of ... analytical techniques for biologic products. + Author and review CMC analytical sections of BLA and other CMC... CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority… 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
- Kelly Services (South San Francisco, CA)
- …partners, and serving as the drug product/analytical lead across all CMC (Chemistry, Manufacturing, and Controls) teams. Additionally, this position will provide ... United States, reporting directly to the Senior Vice President, Head of CMC . **Responsibilities** + Provide strategic leadership for drug product development and… more
- Amgen (Thousand Oaks, CA)
- …such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will actively chart the ... validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring success of commercial approval and launch +… more
- AbbVie (South San Francisco, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie has a long and rich history of ... art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC … more
- Lilly (Indianapolis, IN)
- …and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and regional regulatory scientists) and is responsible for forming ... Lead Global Regulatory Team consisting of regional regulatory scientists, GRA- CMC , GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensures… more
- Lilly (Indianapolis, IN)
- …and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and regional regulatory scientists) and forms and maintains a highly ... Lead Global Regulatory Team consisting of regional regulatory scientists, GRA- CMC , GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensures… more
- Takeda Pharmaceuticals (Boston, MA)
- …as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions + ... business partner leadership role. + Proven track record in delivering enterprise-scale CMC technologies and digital solutions in a GxP-regulated environment. + Deep… more
- Butler America (Chula Vista, CA)
- …and in some cases create, MS Project Plans for R&D Ceramic Matrix Composite ( CMC ) and Prognostic Health Monitoring (PHM) projects. . Gather data to update plans, ... The Following - Create, as necessary, and maintain R&D CMC and PHM project plans weekly Facilitate and drive...up to 3 times per week in association with CMC and PHM projects Standardized visuals such as TRL… more