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Vice President

2 months ago

Redwood City, United States Meet Full time

Meet is partnered with a clinical-stage biopharmaceutical company dedicated to developing therapeutics for the treatment of rare metabolic diseases and they're seeking a Vice President of Manufacturing

Responsibilities:

  1. Lead the design, development, and implementation of transforming CMC functions into a robust global manufacturing and supply group, ensuring agility and reliability with an external vendor network. Partner with the VP of Quality to create a unified platform for global supply.
  2. Manage technical and managerial aspects of external CDMOs and service providers to ensure compliance with global regulations and timely production.
  3. Oversee CMC development programs, including outsourced operations, and collaborate with research, clinical, regulatory, and business teams to support clinical and regulatory timelines.
  4. Ensure timely global CMC submissions in coordination with Quality and Regulatory teams for product registrations.
  5. Build, lead, and develop a high-performance team, providing effective leadership, career development, and alignment with corporate goals.
  6. Collaborate with the VP of Quality to ensure operational compliance and support drug registration and release processes.
  7. Optimize processes, scale-up efforts, and address manufacturing issues efficiently and compliantly.
  8. Assess and recommend long-term manufacturing solutions and facilities aligned with corporate strategy.
  9. Ensure practical, cost-effective manufacturing and analytical approaches for successful product launches.
  10. Direct and monitor the preparation and filing of CMC regulatory submissions, including BLAs, ensuring high-quality documentation and compliance.
  11. Ensure organizational resources support development, launch, and clinical manufacturing needs.

Qualifications:

  1. B.S. required; Ph.D. preferred.
  2. 15+ years in CMC, process development, manufacturing, and supply chain roles in life sciences, with startup/biotech and biologics experience preferred.
  3. Proven success in establishing global commercial supply chains, interacting with regulatory agencies, and managing timely CMC submissions and approvals for biologics.
  4. Strong in leading through influence, problem-solving, and communication.
  5. Flexible with morning, evening, or weekend work; may involve up to 50% domestic and international travel.
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