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
