• Merck & Co. (North Wales, PA)
    … and Commercialization Teams (DCTs) responsible for building and executing CMC development plans.Under the guidance of the CIPM Director & Portfolio Lead, ... be to lead project management efforts to support Chemistry Manufacturing & Controls ( CMC ) product development from First in Human to Transfer to Supply,… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (North Wales, PA)
    … Division / our Manufacturing Division Quality departments and our Research & Development Division / our Manufacturing Division Technical CMC teams for ... leader will interact with our Company's cross-divisional/functional teams from development through commercialization to ensure implementation of the designed quality… more
    HireLifeScience (03/29/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …including (mAb, Drug Substance, Drug Product , or New Modality) process and product development preferred Travel Ability to travel up to 30%. Global and ... activities across the projects for (mAb, Drug Substance, Drug Product , or New Modality) manufacturing, evaluates CMC ...and associated teams for internal and external sites and development projects. Serve as the main interface to internal… more
    HireLifeScience (03/12/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    … quality related to device development and combination product development . This position reports directly to Director , Combination Product ... CMC meeting responsible to assess device and combination product impactWork with cross functional team members effectivelyQualificationsEducation and… more
    HireLifeScience (03/12/24)
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  • Director , CMC Product

    AbbVie (Irvine, CA)
    …with respect to science, time, budget and resources. + Develops and implements a CMC product development plan and updates as necessary in collaboration ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...convenience + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
    AbbVie (03/18/24)
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  • Senior Associate Director /Associate…

    Boehringer Ingelheim (Ridgefield, CT)
    …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible for ... post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory...DMF Annual Report on behalf of the DMF Holder. CMC Development : + Provides US CMC more
    Boehringer Ingelheim (03/16/24)
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  • Senior Director , Regulatory Affairs…

    Teva Pharmaceuticals (West Chester, PA)
    …regulatory colleagues to prepare dossiers for global registration. + Identify and evaluate CMC issues associated with product development including ... Senior Director , Regulatory Affairs CMC , Innovative...+ Relevant technical experience in Analytical (QC, Analytical R&D), process/ product development , or manufacturing + Knowledge of… more
    Teva Pharmaceuticals (01/31/24)
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  • Director , Regulatory Affairs CMC

    Taiho Oncology (Pleasanton, CA)
    Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly...Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development , approval and post… more
    Taiho Oncology (03/26/24)
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  • Director , GRA CMC Pharmaceuticals,…

    Takeda Pharmaceuticals (Boston, MA)
    …organization to think proactively and utilize science and risk based approach to product development and LCM activities. + Contribute to creating and ... CMC experience including experience as an RA CMC product lead, or equivalent industry experience,...Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. +… more
    Takeda Pharmaceuticals (03/13/24)
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  • Director of CMC , Regulatory

    Cymabay Therapeutics (Newark, CA)
    …report to the Chief Regulatory and Compliance Officer. The Director of CMC is accountable for the development and implement global regulatory chemistry, ... manufacturing, and control ( CMC ) strategies for small molecules products from ...a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/ product more
    Cymabay Therapeutics (02/14/24)
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  • Senior Advisor/ Director , Global…

    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 (02/08/24)
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  • Director - CMC Leader in Large…

    J&J Family of Companies (Malvern, PA)
    Director - CMC Leader in Large...Teams (VST). You will see opportunities for team or product development improvements across the TDS organization. ... & Johnson's Family of Companies, is recruiting for a Director - CMC Leader in Large Molecule...not limited to, the creation and implementation of the development strategy, the adherence to the CMC more
    J&J Family of Companies (03/26/24)
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  • Associate Director CMC RA

    Amicus Therapeutics (Marlow, OK)
    …Certification (eg RAC) Professional Work Experience Requirements . 7-10 years' experience in CMC product development , regulatory . Experience in managing ... Associate Director CMC RA Location Marlow, UK...Affairs, Technical Operations, Science and Quality Assurance . Ensure CMC development strategies are aligned with global… more
    Amicus Therapeutics (03/12/24)
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  • Director , CMC Regulatory Affairs…

    Gilead Sciences, Inc. (Foster City, CA)
    …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Director , CMC Regulatory Affairs - Biologics** **KEY RESPONSIBILITIES** The ... Director , CMC Regulatory Affairs for Biologics is responsible for defining...multiple products. + Lead the execution and influence the development of global CMC regulatory strategies, including… more
    Gilead Sciences, Inc. (03/26/24)
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  • Senior Advisor/ Director , Global…

    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 (03/14/24)
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  • Executive Director , Cell Therapy…

    BeiGene (San Mateo, CA)
    …cell therapy development . Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will ... cell therapies is a plus. + Broad understanding of all aspects of CMC including process development , regulatory and quality requirements, analytical … more
    BeiGene (03/08/24)
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  • Director , CMC Biologics, Drug…

    AbbVie (South San Francisco, CA)
    …team. + Actively contribute to cross-functional CMC strategic discussions, ensuring drug product development plans are aligned with the team goals. + Form ... levels and must foster productive collaborations within the global Biologics Drug Product Development organization and with R&D cross-functional partners and… more
    AbbVie (03/18/24)
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  • Director CMC

    Actalent (Edison, NJ)
    …borders and internationally is helpful but not critical Job Summary/Responsibilities: + Drives development of program CMC goals in partnership with the CSO that ... development and manufacture of drug substance and drug product , including analytical methods. + Plan and manage non-GMP...* Experience in both topical and oral dose formulation development . * Experience in preparing CMC components… more
    Actalent (03/16/24)
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  • Director , Cell Culture Process…

    Gilead Sciences, Inc. (Foster City, CA)
    …help create possible, together. **Job Description** ** Director , Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - Foster City, ... impact. Join Gilead and help create possible, together. **Job Description** The Director , Cell Culture Process Development (Pre-Pivotal) will be responsible for… more
    Gilead Sciences, Inc. (03/02/24)
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  • Manager, CMC Regulatory

    Cymabay Therapeutics (Newark, CA)
    CMC submission are aligned with Health Authority requirements and CymaBay product development objectives. The position will provide support for both ... Position Summary The Manager, CMC Regulatory will report to the Director...Manager, CMC Regulatory will report to the Director , CMC Regulatory and will be responsible...development stage and future marketed products for the US… more
    Cymabay Therapeutics (01/19/24)
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