- Kelly Services (South San Francisco, CA)
- …at the forefront of innovative small molecule drug development as the Associate Director of Project Management, CMC . You will play a pivotal leadership ... Kelly(R) Science & Clinical is seeking a CMC Project Manager for a one-year contract opportunity with a leading biopharmaceutical company in South San Francisco,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... all DP-related activities within the project (s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works ... Leads initiatives internal to RA CMC . + Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the… more
- BeOne Medicines (San Mateo, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for...lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and investigator brochures,… more
- AbbVie (North Chicago, IL)
- …interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of ... with CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and develop… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and implementing ... and post-approval changes. The incumbent may manage outsourcing partners in support of project execution. The Associate Principal Scientist may also support … more
- Danaher Corporation (Fargo, ND)
- …of already established contracts and project /program execution. This position reports to the Director of Drug Product CMC and is part of the Drug Product ... liaison for internal project teams, mentoring team members and Associate Project Managers to support their professional growth and ensure high-quality client… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as… more
- AbbVie (North Chicago, IL)
- …and automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, ... ongoing basis . Provide guidance, technical advice, planning, and project management within SM CMC and with...advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support… more
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