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 :
- 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.
- Manage technical and managerial aspects of external CDMOs and service providers to ensure compliance with global regulations and timely production.
- Oversee CMC development programs, including outsourced operations, and collaborate with research, clinical, regulatory, and business teams to support clinical and regulatory timelines.
- Ensure timely global CMC submissions in coordination with Quality and Regulatory teams for product registrations.
- Build, lead, and develop a high-performance team, providing effective leadership, career development, and alignment with corporate goals.
- Collaborate with the VP of Quality to ensure operational compliance and support drug registration and release processes.
- Optimize processes, scale-up efforts, and address manufacturing issues efficiently and compliantly.
- Assess and recommend long-term manufacturing solutions and facilities aligned with corporate strategy.
- Ensure practical, cost-effective manufacturing and analytical approaches for successful product launches.
- Direct and monitor the preparation and filing of CMC regulatory submissions, including BLAs, ensuring high-quality documentation and compliance.
- Ensure organizational resources support development, launch, and clinical manufacturing needs.
Qualifications :
- B.S. required; Ph.D. preferred.
- 15+ years in CMC, process development, manufacturing, and supply chain roles in life sciences, with startup/biotech and biologics experience preferred.
- Proven success in establishing global commercial supply chains, interacting with regulatory agencies, and managing timely CMC submissions and approvals for biologics.
- Strong in leading through influence, problem-solving, and communication.
- Flexible with morning, evening, or weekend work; may involve up to 50% domestic and international travel.
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