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Director Cmc Expert jobs - Boston, MA

Viewing 1 - 10 of 24 jobs

  • Global Regulatory Lead, Associate Director (anti-PDL1) 1 (90122)

    EMD Serono - Billerica, MA

    with RST members * Coordinate with RST members representing CMC, Center of Excellence Product Information and RISM to ensure access to necessary content and functional contacts for dossier(s) * Provide strategic oversight to the SPM (from...

    25 days ago from EMD Serono

  • Global Program Regulatory Affairs Manager / Associate Director

    Novartis Oncology - Cambridge, MA

    The Global Program Regulatory Affairs Manager / Associate Director provides regulatory leadership for early projects in ... and chemistry manufacturing control (CMC). • Applies extensive technical expertise and has full knowledge of other...

    30+ days ago from Biospace

  • DIRECTOR, GENE THERAPY DEVELOPMENT

    Trn - Framingham, MA

    and manufacturing plans. Serve as a subject matter expert (SME) related to viral and gene therapy-related ... of gene therapy biologics development, CMC, and regulatory submission requirements, processes and considerations ·...

    16 days ago from ZipRecruiter

  • Director, Quality Control

    Biogen - Cambridge, MA

    External Posting Title Director, Quality Control Job Description This is a Cambridge based position reports directly to ... Quality control, Technical Development, CMC, Regulatory, QA and Manufacturing. Location Cambridge, MA, US Job Category...

    23 hours ago from Biogen

  • Associate Director, Analytical Development

    Momenta Pharmaceuticals - Cambridge, MA

    Experience Strong Analytical Chemistry background with expert level skills in the characterization and analysis of ... Demonstrated experience with the preparation of analytical CMC sections of regulatory submissions is preferred...

    20 days ago from Momenta Pharmaceuticals

  • Associate Director, Analytical Development (284286-811)

    Momenta Pharmaceuticals - Cambridge, MA

    Experience * Strong Analytical Chemistry background with expert level skills in the characterization and analysis of ... Demonstrated experience with the preparation of analytical CMC sections of regulatory submissions is preferred *...

    30+ days ago from Momenta Pharmaceuticals

  • Global Program Regulatory Affairs Manager / Associate Director

    Novartis Pharmaceuticals - Cambridge, MA

    The Global Program Regulatory Affairs Manager / Associate Director provides regulatory leadership for early projects in ... and chemistry manufacturing control (CMC). • Applies extensive technical expertise and has full knowledge of other...

    30+ days ago from Novartis Pharmaceuticals

  • Director, Quality Control

    Biogen Idec - Cambridge, MA

    clinical pipeline. • Act in the capacity of technical expert for Analytical methodologies to be able to resolve quality ... Quality control, Technical Development, CMC, Regulatory, QA and Manufacturing.• PhD in Life Sciences with 15+ years of...

    30+ days ago from Biogen Idec

  • Director/Senior Director, Formulation Development (172995-106)

    Infinity Pharmaceuticals - Cambridge, MA

    Position Description: The Director/Sr. Director for Formulation Development will report to the VP for Pharmaceutical ... formulation design, characterization, and development and CMC activities. Responsibilities include: * Lead, mentor, and...

    30+ days ago from Infinity Pharmaceuticals

  • Associate Director, Late Stage Analytical Product Development

    Laguna Source - Lexington, MA

    functional strategic teams preparing analytical sections of CMC, BLA and MAA regulatory filings. * Driving the ... required. * Regulatory filing experience contributing to CMC, BLA and MAA submissions. * Subject matter expertise...

    30+ days ago from Laguna Source