Vice President of CMC Operations

Job Summary

Seeking an experienced leader, the full-time remote Vice President of CMC Operations will define strategy and drive execution for pharmaceutical Chemistry, Manufacturing & Controls (CMC) from Phase 3 readiness through regulatory approval and commercial launch, while ensuring alignment with development and commercial objectives.

Key Responsibilities

• Own sponsor-side pharmaceutical CMC strategy and decision-making from Phase 3 through commercial launch
• Translate CMC gaps, risks, and regulatory expectations into practical execution plans with clear priorities and timelines
• Lead technology transfer, manufacturing campaign planning, and commercial readiness while identifying and mitigating risks

Required Qualifications

• BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline
• 15+ years of pharmaceutical or biotechnology industry experience in CMC and related functions
• Demonstrated experience as the sponsor-side CMC lead for a late-stage pharmaceutical development program
• Hands-on experience with regulatory submissions and health authority interactions
• Strong knowledge of FDA CMC expectations and cGMP requirements