Associate Director, CMC Project Management

Role: Experienced Project Manager leading cross-functional CMC activities for early-stage biopharma development programs, including process development, analytical, quality, regulatory, and supply chain functions. Primary objectives involve developing integrated project plans, coordinating external partners, and ensuring successful program execution from early development through late-stage and regulatory filings. Responsibilities include risk management, scenario planning, standardizing reporting processes, and supporting operational excellence and budget planning. Requirements: BS/MS in Biotechnology, Chemical Engineering, Biology, or related field; 10+ years in CMC or biotech/pharma functions with at least 5 years in project/program management supporting drug development. Proven ability to lead complex, multi-stakeholder programs, with strong knowledge of cGMP, quality systems, and regulatory processes. Preferred qualifications include advanced degrees or certifications (e.g., PhD, MBA, PMP). High-value specifics: supporting early to late-stage development, managing external vendors and CMOs, experience with biologics or infectious disease programs, and working within GxP environments. Work setup: onsite in San Francisco, requiring three days/week presence.