- Genentech (South San Francisco, CA)
- …(TDL) to manage technical development team(s) in defining and implementing CMC strategies and activities associated with developing clinical candidates from ... the Technical Development Lead (TDL) and technical teams to define the CMC strategy and objectives for 3-5 projects across various platforms (large/small molecules,… more
- Lilly (Indianapolis, IN)
- …in a collaborative and fast-paced work environment. + Lead and oversee CMC process development activities for novel payloads and drug-linkers within ADC programs, ... ensure manufacturability and facilitate smooth transition from early research to CMC development. + Develop scalable, robust, and reproducible processes for payload… more
- Gilead Sciences, Inc. (Foster City, CA)
- …rapidly growing Foster City team. A solid understanding of GMPs and CMC requirements is expected. Mass Spectrometry expereince is a must.** **Responsibilities:** + ... overseeing all analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +… more
- AbbVie (North Chicago, IL)
- …automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with ... . Provide guidance, technical advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support to laboratory… more
- 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