• Manager , CMC Operations

    Lilly (Philadelphia, PA)
    …to make life better for people around the world. **Position Overview:** The Manager , CMC Operations is responsible for independently managing technical ... transfer documents for Lilly and CMOs + Support the CMC team in ensuring that internal and external manufacturing...deployed products + Be a key resource for manufacturing operations and analytical troubleshooting at CMOs + Demonstrate a… more
    Lilly (01/08/26)
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  • Senior Manager , CMC Global…

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
    Otsuka America Pharmaceutical Inc. (12/02/25)
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  • Manager , Clinical Operations…

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager , Clinical Operations will also coordinate reporting and review of CRO ... **Job** **Summary** The Manager , Clinical Operations works closely with...manage monitoring oversight activities including managing Clinical Monitoring Consultants ( CMC ) contracted to perform monitoring oversight duties as well… more
    Otsuka America Pharmaceutical Inc. (01/09/26)
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  • Manager , Regional Regulatory Lead - LCM

    CSL Behring (King Of Prussia, PA)
    …Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk ... and decision making. Ensures bi-directional communication with stationed region commercial operations and GRA. With support, engaging with health authority (HA) in… more
    CSL Behring (11/01/25)
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  • Senior Manager , Global Product Quality…

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations , QC and Clinical Supplies Operations , and other Otsuka Companies,… more
    Otsuka America Pharmaceutical Inc. (12/03/25)
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  • Associate Project Manager…

    Eurofins US Network (Lancaster, PA)
    …in pharmaceutical sciences, analytical chemistry, or biologics. + Experience in GMP lab operations , especially in CMC testing. + Proven ability to manage complex ... and products. **Job Description** **Role Overview** The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing Good Manufacturing… more
    Eurofins US Network (12/30/25)
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  • Project Coordinator

    Kelly Services (Malvern, PA)
    …solution provider and business unit of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month + engagement at one of our Global clients in ... phase changes of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** + Accountable for… more
    Kelly Services (12/17/25)
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  • Senior Manager , Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations , etc.) to develop ... global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements,… more
    Otsuka America Pharmaceutical Inc. (11/20/25)
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  • Regulatory Affairs Consultant - Labeling…

    Parexel (Harrisburg, PA)
    Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations ... markets. In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH,...* Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in… more
    Parexel (12/13/25)
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  • Sr. Non-Clinical Biostatistician

    Sanofi Group (Swiftwater, PA)
    …diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D ... support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration… more
    Sanofi Group (12/17/25)
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