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Job

SVP/VP of CMC

  • Location

    New York City

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Experience dependent

  • Contact:

    Marin Haugo

  • Contact email:

    m.haugo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    REF-2

  • Published:

    3 months ago

  • Expiry date:

    2022-03-13

  • Startdate:

    ASAP

Our client is a small, clinical-stage, biopharma company looking for a VP of CMC. The client is looking for an experienced CMC head with demonstrated experience in advancing biologic therapies.  They are looking for an exceptional individual who can come in and hit the ground running as part of an innovative team, developing breakthrough therapies to help cancer patients.  This role is hybrid and based out of their NYC office. 

Duties and Responsibilities

  • Lead the day-to-day operations of the CMC organization, demonstrating leadership, management skill, and scientific expertise in directing teams in drug substance and drug product process development and manufacturing, quality control, analytical development, testing, and clinical supply chain.
  • Coordinate with leadership in the execution of the Company’s CMC strategy to support and advance Actinium’s clinical programs, including commercial process development and BLA planning.
  • Demonstrate scientific, technical, and compliance knowledge in all aspects of biopharmaceutical drug development and manufacturing operations.
  • Manage and direct CMC teams to implement strategies for process risk assessment, characterization, and validation studies, including preparation and review of protocols and reports as well as oversight of study execution conforming to regulatory standards.
  • Collaborate with internal and external partners in designing experimental studies to establish critical process parameters, critical control points, and product quality characteristics.
  • Establish and maintain collaborative partnerships with the CMO to achieve project and program goals, ensure product quality, and support the clinical advancement of the Company’s pipeline programs.
  • Prepare and manage project timelines and budgets to achieve product development goals.
  • Prepare data, reports, and CMC documents to support regulatory submissions, including BLA planning and submission.

Qualifications:

  • MS or PhD in Chemical or Biochemical Engineering, Cellular Biology, Biochemistry, or related discipline
  • A proven leader with a minimum of ten (10) years of industry experience with a focus on the development of therapeutic biologics for early and late-stage products 
  • Prior experience working at a small biotech company is essential
  • Prior experience with radiopharmaceuticals is desired
  • Demonstrate deep knowledge and understanding of compliance requirements
  • Prior experience with BLA preparation and submission