Description

You will lead the global CMC strategy for late-stage oncology programs, driving technical direction, regulatory submissions, and supply continuity to enable rapid, compliant product advancement. You will partner cross-functionally and serve as the senior CMC leader on program teams.

Requirements

• PhD (strongly preferred) or MS in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
• 15+ years progressive CMC experience with strong focus on small molecules
• Demonstrated leadership of CMC from early development through commercialization
• Proven experience leading global regulatory submissions and interacting with major health authorities (FDA, EMA, PMDA)
• Deep expertise in small molecule API and drug product development, manufacturing, and control strategies

Responsibilities

• Own integrated global CMC strategy across development and commercial programs
• Serve as senior CMC leader on program and portfolio teams, accountable for timelines, risks, and deliverables
• Drive risk-based CMC decision-making balancing speed, quality, and product robustness
• Provide strategic oversight of drug substance and drug product development, control strategy, and lifecycle optimization
• Partner with PDM leadership to ensure technical readiness for late-stage development, PPQ, validation, commercial supply, and launch