• Principal Scientist, Engineering

    Merck (West Point, PA)
    …and influences process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC ... transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group… more
    Merck (12/10/25)
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  • Director, Global Regulatory Leader

    J&J Family of Companies (Spring House, PA)
    …Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
    J&J Family of Companies (12/04/25)
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  • Associate Principal Scientist, Downstream Vaccines…

    Merck (West Point, PA)
    …leading small technical development teams + Experience in authoring and reviewing CMC regulatory documentation + Experience with process and technology transfer ... The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected… more
    Merck (11/26/25)
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  • Dir, Engineering, CMC Leader for Biologics

    Merck (West Point, PA)
    …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more
    Merck (12/09/25)
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  • CMC Biologics Quality Control Director,…

    Teva Pharmaceuticals (West Chester, PA)
    CMC Biologics Quality Control Director, Physiochemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities… more
    Teva Pharmaceuticals (10/18/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
    Otsuka America Pharmaceutical Inc. (11/20/25)
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  • Senior Manager, Global Product Quality - Biologics

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
    Otsuka America Pharmaceutical Inc. (12/03/25)
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  • Associate Director, Biopharmaceutics

    Organon & Co. (Plymouth Meeting, PA)
    …+ Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other cross-functional activities, as ... be responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, INDs,… more
    Organon & Co. (10/10/25)
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  • Project Engineer

    Globus Medical, Inc. (Audubon, PA)
    …studies, analytical characterization, and process validation + In-depth understanding of CMC (Chemistry, Manufacturing, and Controls) regulatory considerations + ... technical reports, and ensures strict compliance with applicable quality and regulatory standards + Possesses in-depth knowledge of CBER (Center for Biologics… more
    Globus Medical, Inc. (11/06/25)
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  • CMCPM Radiopharmaceuticals

    Lilly (Philadelphia, PA)
    …make life better for people around the world. **Organizational Overview:** CMC Project Management is responsible for leading the creation, development, communication ... and implementation of integrated CMC plans for assets from portfolio entry to global...goals (working closely with asset leadership, PPM, clinical/medical, and regulatory partners). + Lead the creation, development, communication and… more
    Lilly (10/18/25)
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