- 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
- 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
- AbbVie (North Chicago, IL)
- …Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral ... with key Analytical stakeholders across organizations as well as cross-functional CMC business partners in the characterization of biologics compounds and provide… more
- Bristol Myers Squibb (Madison, NJ)
- … CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments. + Provides technical quality expertise and compliance oversight ... the commercial program (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.The PQL must… more
- Merck (Elkhorn, NE)
- …cross‑functionally with Discovery Biology, Protein Sciences, Structural Biology, and Developability/ CMC to advance molecules from hit identification through lead ... teams to evaluate potency, MOA, and functional readouts + Work with CMC teams to screen for developability (solubility, stability, aggregation, viscosity, PTM… more
- Lilly (Indianapolis, IN)
- …in a dynamic environment. We are seeking an experienced, innovative, and motivated CMC Analytical Chemistry Advisor or Senior Advisor to support the development of ... of antibody-drug conjugates, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry. Provides technical… more