- AbbVie (Irvine, CA)
- …. Job Description Further develop your expertise and join our team as Director , CMC Product Development . Must have Medical ... Device experience. The Product Development Director (PDD) will be a member...requirements, budget and resources. + Multiple product development experiences of leading a CMC team… more
- AbbVie (North Chicago, IL)
- …5-10 years of working experience required in the same/similar role or in related CMC function. + Multiple product development experiences of leading a ... participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. timelines, risks and mitigations in… more
- Danaher Corporation (Fargo, ND)
- …that safeguard and improve human health. We are seeking a strategic and technically accomplished Director of Drug Product CMC to lead client-facing drug ... + Serve as the primary CMC technical lead for drug product development projects, acting as a key liaison between clients and internal cross-functional teams.… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... Demonstrated deep technical knowledge and experience of small molecule drug product development , commercialization and manufacturing processes. + Prior… more
- Lilly (Indianapolis, IN)
- …scientific knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC regulatory experience **Additional Information** ... better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ...Ensures appropriate definition and approves regulatory strategies for global CMC development and manufacturing changes. + Maintains… more
- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you... CMC experience including experience as an RA CMC product lead with late-stage development… more
- Lilly (Indianapolis, IN)
- … Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible ... P2 in the new role. **Position Summary:** The Associate Director , CMC Project Management will provide strategic...and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional… more
- Lilly (Indianapolis, IN)
- …strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content. + Makes decisions on CMC… more
- Lilly (Boston, MA)
- … Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible ... teams and therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams.… more
- J&J Family of Companies (Horsham, PA)
- …successful CMC regulatory lifecycle strategies is required. + Expertise in product development and how it is applied to global regulatory strategies ... & Johnson Innovative Medicine R&D is recruiting for a Director , CMC (Chemistry, Manufacturing and Controls) Regulatory...CMC regulatory professionals and will be responsible for development , implementation, and maintenance of global CMC … more
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