- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth of experience to ... leadership on key pipeline projects while also supervising and mentoring a team of CMC Product Development Directors. A key function of the role is to serve… more
- AbbVie (Irvine, CA)
- …Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Product Development Director (PDD) will be a member ... requirements, budget and resources. + Multiple product development experiences of leading a CMC team...product development experiences of leading a CMC team through regulatory submissions (NDA/BLA/PMA preferred). + Must… more
- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- Merck (North Wales, PA)
- …is responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product ... success together with risk mitigation measures. + Lead the development , communication, and review of the CMC ... in-license/due diligence review, product divestment and product withdrawal. + Support new technology development .… more
- Takeda Pharmaceuticals (Lexington, MA)
- …investigational, registration and/or pos-approval strategies for assigned products as GRA CMC Product Lead. Represents and contributes to Regulatory, ... life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently...executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.… more
- J&J Family of Companies (Horsham, PA)
- …technical expertise and input to the CMC team to facilitate successful product development globally + Leads the preparation of regulatory dossiers for ... Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position...issues to Management Sphere of Authority + Ensures the CMC development and commercial product … 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 ... global program team/governance and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC … more
- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...experience including experience as an RA CMC product lead with late stage development , international… more
- Lilly (Indianapolis, IN)
- …and evolving global regulatory expectations + 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 risk-based decisions on… more
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing coaching and feedback… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... early and late phase drug development candidates within the team to support overall CMC development plan. - Represent CMC development project teams… more
- Gilead Sciences, Inc. (Foster City, CA)
- …CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development , manufacturing and quality teams on the construction, ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our...Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:** **_*This is a site based position… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, MA with the ... Minitab) to drive strategic decision-making, define product strategy, and support roadmap development for product development ; Lead cell and gene therapy… more
- Hubbell Power Systems (Hamilton, OH)
- …and marketing plans. Maintain and grow market share through incremental New Product Development programs and market-based pricing decisions. Responsible for ... Business Unit Director ( CMC ) - Hamilton, OH Apply...45015-1369 Company: Hubbell Incorporated Job Overview Responsible for all Product Management and Engineering activities to assigned CMC… more
- Organon & Co. (Plymouth Meeting, PA)
- …and incorporating knowledge of the changing regulatory environment. + Embed regulatory CMC activities within product development plans that outlines ... ) is responsible for Regulatory Chemistry, Manufacturing and Controls ( CMC ) aspects of clinical phase through market product... scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies… more
- Vera Therapeutics (Brisbane, CA)
- …in early-to-late development to create high quality regulatory submissions that support product development strategy. * Author and review Clinical and CMC ... team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be...communicating regulatory strategies to stakeholders. * Industry experience in CMC development of biologics preferred. * Experience… more
- AbbVie (Worcester, MA)
- …Instagram, YouTube and LinkedIn. Job Description Position will be responsible for CMC leadership and project management for existing and new biologics projects from ... plans, budgets, timelines and strategy; biologics projects at all stages of development are included, from phase I through commercial. *Must present technical… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Analytical Development Director + **Location:** Cambridge, MA **About the Job** We are an innovative global healthcare company with one purpose: ... Ready to get started? Sanofi is seeking an **Analytical Development Director ** to lead the analytical group...which is part of the synthetic platform within Global CMC Development . We are striving to become… more
- Kelly Services (Ballwin, MO)
- …regulatory activities, especially CMC aspects of new API and pharmaceutical product development . **Title** : Regulatory Affairs Director **Location** : ... Scientific is leading the search for a **Regulatory Affairs Director ** - a permanent role with a pharmaceutical company...role with a pharmaceutical company focused on discovery and development of novel therapeutics to address unmet medical needs.… more
- Bristol Myers Squibb (Seattle, WA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Executive Director , Drug Product Process Development is accountable ... licensure. + Understanding of ICH guidelines + Experience with partnering externally on product development + Understanding of enterprise network strategy and … more
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