- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …work effectively with CDMOs. The position reports to Executive Director , CMC & Product Development . **Job Description** **Pharmaceutical Development ... Director , Formulation Development is an experienced...they will empower decision making while serving as a product development expert to all relevant internal… 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
- AbbVie (North Chicago, IL)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Director will be fully responsible for providing CMC leadership and ... initiatives. + Independently lead complex and/or hybrid cross-functional PDS&T product teams. Represent the CMC team and/or...with at least 12+ years of relevant experience. + CMC development experience through IND and/or NDA/MAA.… 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 (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution ... of multiple radiopharmaceutical CMC development and manufacturing programs supporting various...+ Familiarity with Stage 1-3 process validation and pharmaceutical product lifecycle management. + Excellent interpersonal, verbal, and written… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and ... the brightest minds in biopharma. **Position Summary** The Scientific Director /Senior Director , CMC Team Leader...to meet global R&D project needs . Supporting the Product Development portfolio, which includes small molecules,… 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)
- …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 (Indianapolis, IN)
- … 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
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... multiple products. + Lead the execution and influence the development of global CMC regulatory strategies, including...risk mitigation strategies to ensure right first-time approvals of product submissions. + Lead the execution of these global… more
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