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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:

  • Lead the transition of clinical functions to a global manufacturing and supply group, ensuring agility and vendor network efficiency while partnering with the Head of Quality for a scalable platform.
  • Oversee the Plan of Record for Phase 3 studies in rare disease, including drug substance and product manufacturing, supply chain risk management, and executive leadership for clinical supply teams.
  • Enhance manufacturing and supply chain operations by recruiting key resources, defining processes, and managing daily execution while working with Quality, Clinical Operations, Regulatory, and Finance teams.
  • Manage externalized manufacturing and logistics, ensuring vendor performance, risk mitigation, and the establishment of global supply strategies for multiple indications.
  • Implement and maintain robust systems for manufacturing, inventory, and supply, and lead teams to resolve deviations and support S&OP processes for clinical and commercial supply.
  • Support global submissions, optimize processes, and solve complex manufacturing issues while aligning with corporate strategy and ensuring effective product launches.
  • Oversee financial management of supply, including budgeting and forecasting, and work with CDMOs and MSAT teams for continuous improvement.
  • Develop and manage contracts for services and materials, ensuring compliance and cost-efficiency, and review technical documentation to ensure regulatory compliance and effectiveness.


Qualifications:

  • B.S. required; Ph.D. preferred.
  • 15 Yrs+ in progressive Manufacturing and Supply Chain leadership roles within like Lifesciences Start-up/ Biotech organizations
  • Rare Disease experience required
  • Commercial launch experience required
  • Biologics process and manufacture experience required.
  • Proven track record in establishing global commercial product supply chains, interacting successfully with regulatory agencies, and managing timely global submissions and approvals for biologics.
  • Strong leadership skills in influencing, problem-solving, and driving solutions; excellent communication at all organizational levels; a sense of humor and humility are essential.
  • Flexible schedule required for meetings across time zones and with offshore vendors.
  • Position may require domestic and international travel (up to 20%)



If you're interested in hearing more about this opportunity please apply or reach out to carlos@peoplewithchemistry.com