- 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
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems ... the approval and commercialization of critical medicines. + Supports the USP CMC team to develop technical documents and tools on localizing manufacturing of… more
- Lilly (Indianapolis, IN)
- …procedures, data requirements and summaries. + Author technical reports and CMC related documents including sections in regulatory submission documents ... (eg, IND, IMPD, BLA). + Publish original research externally, travel to conferences to share and learn about the external environment and latest trends and technologies, leveraging those learnings on novel Lilly medicines. + Design and execute laboratory… 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 (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
- 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
- Sanofi Group (Swiftwater, PA)
- …recombinant proteins, manufacturing support, Phase 3 clinical material production, CMC strategy development, and new product introductions. Your leadership will ... operations** , with strong understanding of GMP requirements and global CMC projects + Experience leading in **matrix organizations** with cross-functional,… more
- Kelly Services (Malvern, PA)
- …phase changes of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** + Accountable for ... departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead Process-Fit-to-Plant… more
- J&J Family of Companies (Spring House, PA)
- …discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development, and Clinical Supply Chain. This organization ensures ... delivery system is robustly developed, scaled, and supplied under rigorous quality and regulatory standards. We are seeking a Global Head of Data Science & Digital… more
- Takeda Pharmaceuticals (Lexington, MA)
- …CMO and vendors, works closely with drug product, quality, regulatory , program leadership, etc. and establish strategic working relationships. **Responsibilities:** ... plans as required. + Evaluates impact of decisions across CMC functions. + Makes significant independent contributions to complex...plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a plus +… more