• Merck & Co. (North Wales, PA)
    …for building and executing CMC development plans.Under the guidance of the CIPM Director & Portfolio Lead , the core responsibility of this individual will be ... products that improve human health and business.Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to...to lead project management efforts to support Chemistry Manufacturing &… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
    HireLifeScience (03/12/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology ... preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology… more
    HireLifeScience (03/12/24)
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  • Director , Regulatory Affairs CMC

    Taiho Oncology (Pleasanton, CA)
    …an agreed upon plan. Performance Objectives: + Independently develops global regulatory CMC Strategy and Risk Assessments, and communicate such strategy ... Director , Regulatory Affairs CMC Pleasanton, CA,...will play a pivotal and visible role in advancing CMC filing strategy for investigational/ developmental products… more
    Taiho Oncology (03/26/24)
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  • Director , CMC Regulatory Affairs…

    Gilead Sciences, Inc. (Foster City, CA)
    …integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. **JOB DESCRIPTION** + Lead CMC regulatory strategy for a single or multiple ... 35 countries worldwide, with headquarters in Foster City, California. ** Director , CMC Regulatory Affairs - Biologics** **KEY...Affairs, PDM, and other functional groups across Gilead. + Lead CMC strategies, assess risks, and develop… more
    Gilead Sciences, Inc. (03/26/24)
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  • Director , GRA CMC Pharmaceuticals,…

    Takeda Pharmaceuticals (Boston, MA)
    …bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC ... an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy . Establish collaboration with Global CMC teams and leadership… more
    Takeda Pharmaceuticals (03/13/24)
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  • Senior Director , Regulatory Affairs…

    Teva Pharmaceuticals (West Chester, PA)
    Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Feb 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to...CMC (Innovative Medicine) you will: + Influence the strategy and assess the quality of documents for regulatory… more
    Teva Pharmaceuticals (01/31/24)
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  • Director - CMC Leader in Large…

    J&J Family of Companies (Malvern, PA)
    Director - CMC Leader in Large Molecule Biologics (1 of 2) - 2406161628W **Description** Janssen Research & Development, LLC, a division of Johnson & Johnson's ... Family of Companies, is recruiting for a Director - CMC Leader in Large Molecule...Metabolism, Immunology, Neuroscience, Oncology and Pulmonary Hypertension. Within the CMC group, you will lead multiple … more
    J&J Family of Companies (03/26/24)
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  • Director of CMC , Regulatory

    Cymabay Therapeutics (Newark, CA)
    …are Tuesday, Wednesday and Thursday. ESSENTIAL DUTIES AND RESPONSIBILITIES + Function as regulatory CMC lead for assigned products + Provide strategic CMC ... POSITION SUMMARY The Director of CMC , Regulatory will report...development through post-approval + Develop and execute the regulatory strategy ( CMC aspects) to support the lifecycle… more
    Cymabay Therapeutics (02/14/24)
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  • Executive Director , Cell Therapy…

    BeiGene (San Mateo, CA)
    …on programs from a pre-clinical stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions ... We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy...for cell therapy trials. + Develop a vendor selection strategy to select services for development and manufacturing of… more
    BeiGene (03/08/24)
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  • Director , CMC Biologics, Drug…

    AbbVie (South San Francisco, CA)
    …and LinkedIn. Job Description Position Description: For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader to ... lead a diverse team of pharmaceutical development scientists supporting...bar for the team. + Actively contribute to cross-functional CMC strategic discussions, ensuring drug product development plans are… more
    AbbVie (03/18/24)
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  • Senior Specialist, Project Management, Chemistry…

    Merck (Rahway, NJ)
    …building and executing CMC development plans. Under the guidance of the CIPM Director & Portfolio Lead , the core responsibility of this individual will be to ... that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to... lead project management efforts to support Chemistry Manufacturing &… more
    Merck (03/19/24)
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  • AD Drug Substance Analytic - External Alternative…

    Boehringer Ingelheim (Ridgefield, CT)
    **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal ... Therapeutic Product (ATMP) projects. The Associate Director , Analytical/QC will be responsible for leading activities related to Analytical Development/Quality… more
    Boehringer Ingelheim (03/06/24)
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  • Senior Director - Analytical Regulatory…

    Gilead Sciences, Inc. (Foster City, CA)
    …We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster ... 35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr Director more
    Gilead Sciences, Inc. (01/19/24)
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  • Director , Global Commercial…

    J&J Family of Companies (Horsham, PA)
    Director , Global Commercial Strategy , Autoantibody, Maternal Fetal - 2406174883W **Description** Johnson & Johnson Innovative Medicine is currently recruiting ... for a Director , Global Commercial Strategy , Autoantibody, Maternal Fetal...to build the market + Partner with MFI Commercial director to lead Global Commercial teams across… more
    J&J Family of Companies (03/26/24)
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  • Director , Global Commercial…

    J&J Family of Companies (Horsham, PA)
    Director , Global Commercial Strategy , Autoantibody - 2406172760W **Description** Johnson and Johnson Innovative Medicine is recruiting for a Director , Global ... from autoantibody diseases. This role leads the asset-level and cross-indication strategy and workstreams that will ensure the successful development and… more
    J&J Family of Companies (03/13/24)
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  • Director , Early Phase Analytical…

    AbbVie (North Chicago, IL)
    …Biologics CMC to deliver high-quality drug products for patients. The Director , Biologics ARD will lead the Analytical Development-Early Phase group within ... within Biologics Analytical R&D and in line with the Biologics CMC Development/AbbVie strategy for NBEs. + Recruit, promote, and retain top talents via… more
    AbbVie (03/18/24)
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  • Director US Regulatory Strategy

    Lundbeck (Deerfield, IL)
    Director US Regulatory Strategy - Remote opportunity Requisition ID: 5048 Location: Deerfield, Illinois, US Do you want to join a team where the mission is ... the greater United States, preferably East Coast or Midwest **SUMMARY:** The Director , US Regulatory Affairs Strategy , oversees the implementation of regulatory… more
    Lundbeck (02/17/24)
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  • Director , Drug Product Analytical Research…

    Pfizer (Groton, CT)
    …and develop drug candidates from early phases of development to commercial launch. As a Director in the group you will lead a team of analytical scientists to ... development projects + Define and drive the analytical development strategy in full alignment with the other CMC...and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's… more
    Pfizer (02/22/24)
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  • Director , Pharmacometrics…

    Organon & Co. (Jersey City, NJ)
    **Job Description** **The Position** The Director , Pharmacometrics & Biopharmaceutics Lead is responsible for devising the program-level modeling and simulation ... strategy and providing oversight thereof. The responsibility includes identification...technical aspects of modeling efforts and modeling reports. The Director , Pharmacometrics & Biopharmaceutics also will have responsibility for… more
    Organon & Co. (03/13/24)
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