Director, CMC Team Lead
On-site · New Haven, Connecticut, United States
Job Summary
Director, CMC Team Lead responsible for leading the CMC strategy and execution across the asset lifecycle from Candidate Selection through First Approval. Oversees cross-functional leadership of drug substance, drug product, analytical, quality, regulatory CMC, and clinical supply to deliver on critical milestones; develops the integrated CMC Development Plan, drives timely submissions and approval-readiness, and manages dependencies and governance with enterprise teams. This role emphasizes coordinating strategy with operational execution, risk management, and cross-functional decision making to accelerate patient impact and ensure governance alignment. The role requires a strong track record in biopharma, program leadership, and influencing senior stakeholders; the team operates primarily in an office environment with in-person collaboration four days per week. Desirable: prior liaison experience with corporate partners and advanced MS Office capabilities.
Required Qualifications
- Minimum of 8-10 years of experience in the biopharmaceutical industry
- prior experience in a CMC leadership role
- Strong communication, leadership, and collaboration skills
- Solid understanding of drug development and supply processes
- Demonstrated ability to build, coordinate, and lead teams
- Proficient in English (spoken and written)
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