Associate Director, CMC Project Management
$210,000–$260,000 year
Hybrid · South San Francisco, California, United States
Job Summary
Lead End-to-End CMC leadership and cross-functional integration to drive integrated CMC development, manufacturing, and commercialization programs. Oversee program governance, budgets, timelines, invoices, reports, and regulatory filings support; serve as the CMC representative on program governance, and partner with Drug Substance, Drug Product, Analytical, QA, and Finance to ensure timely, quality, and compliant delivery. Drive external manufacturing strategy with CMOs/CDMOs, establish governance, monitor performance metrics and KPIs, and manage risk related to capacity, quality, and supply continuity. Demonstrate strategic thinking with execution discipline, maintain strong cross-functional collaboration, and communicate risks and progress to senior leadership. Anticipated salary range for on-site South San Francisco is $210,000-$260,000, with final offers contingent on experience and other factors.
Required Qualifications
- Advanced degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related field (PhD, MS, or equivalent)
- 9+ years of experience in biopharma CMC development with increasing leadership responsibility
- Proven success leading programs through commercialization including NDA filing and launch
- Deep expertise in CMC development, manufacturing, and regulatory requirements
- Strong ability to lead cross-functional, matrixed teams
- Experience managing CMOs/CDMOs at a strategic level with governance
- Excellent communication, influence, and leadership skills
- Ability to balance technical rigor with business and commercial considerations
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