• Senior Manager , Global Product Quality…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... The Senior Manager , Global Product Quality - Biologics is responsible...in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role… more
    Otsuka America Pharmaceutical Inc. (12/03/25)
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  • Principal Manager , R&D GMP Pharmaceutical…

    Takeda Pharmaceuticals (Lexington, MA)
    …Quality processes and operational efficiency. + Contribute technical quality content to regulatory filings and collaborate with CMC submission teams. + ... the best of my knowledge. **Job Description** **About the role** The Principal Manager , R&D GMP Pharmaceutical Sciences Quality EU & US provides Quality oversight… more
    Takeda Pharmaceuticals (11/27/25)
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  • Manager - MSAT Downstream Lead

    ThermoFisher Scientific (Plainville, MA)
    …we serve. We This position is part of Chemistry, Manufacturing and Controls ( CMC ) Development team and part of Manufacturing Science and Technology (MSAT). **Job ... Title: Manager - MSAT Downstream Lead** **Location:** US - Massachusetts...valid conclusions; and make decisions. + Detailed understanding of regulatory guidelines (FDA, EMA, and other relevant authorities). +… more
    ThermoFisher Scientific (12/18/25)
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  • Associate Director, Principal Product Quality Lead

    Bristol Myers Squibb (Devens, MA)
    … CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments. + Provides technical quality expertise and compliance oversight ... the commercial program (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.The PQL must… more
    Bristol Myers Squibb (01/01/26)
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  • Sr. Non-Clinical Biostatistician

    Sanofi Group (Waltham, MA)
    …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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  • Senior Vice President, Global Development…

    Bristol Myers Squibb (Cambridge, MA)
    …program goals in compliance with GCP, ICH and other global regulatory requirements + Provides comprehensive strategic leadership for 2,100+ multi-site organization ... experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and… more
    Bristol Myers Squibb (11/25/25)
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  • Vice President, Global Program Leader (GPL)…

    Takeda Pharmaceuticals (Boston, MA)
    …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
    Takeda Pharmaceuticals (10/23/25)
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