- Sumitomo Pharma (Lincoln, NE)
- …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
- Lilly (Indianapolis, IN)
- …energetic leader who will define and lead activities with external synthetic CMC collaborations. This role will require significant CMC knowledge, creativity, ... _Ensure Alignment_ : Work closely with cross-functional leaders across Lilly CMC , Quality, Procurement, and Safety to translate PRD/SMDD strategic requirements into… 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
- Adecco US, Inc. (Morristown, NJ)
- Adecco Healthcare & Life Sciences is seeking a skilled ** CMC Regulatory Technical Writer II** to support a global pharmaceutical client in lifecycle management (LCM) ... IMPD) by authoring and reviewing Chemistry, Manufacturing, and Controls ( CMC ) documentation. The ideal candidate works independently, collaborates across multiple… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …the approval and commercialization of critical medicines. + Supports the USP CMC team to develop technical documents and tools on localizing manufacturing of ... medical products in LMIC. + Identify CMC risks and support the development of mitigations and...by leadership. + Other duties as assigned related to CMC workstream as directed by CMC technical… more
- WuXi AppTec (Austin, TX)
- **Overview** Technical Marketing Specialist- CMC (San Diego, CA) - Analyze pharmaceutical project and technical requirements for CMC projects for business ... engineering, biochemistry, pharmaceutical project management, Chemistry, Manufacturing, and Controls ( CMC ) management, applying HPLC, LCMS, UV, IR; Develop scientific… more
- 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