Senior Vice President, CMC

Role: Senior Vice President (SVP), CMC, providing strategic and operational leadership for Manufacturing Science & Technology (MSAT) and Analytical Sciences in a late-stage biopharmaceutical company. Objectives: oversee commercial and late-stage development manufacturing, analytical development, product lifecycle, process validation, technology transfer, and regulatory support to ensure reliable, compliant, and scalable supply. Responsibilities: lead technical teams supporting manufacturing, lifecycle management, process improvements, investigations, and regulatory submissions; oversee external vendor collaborations; partner with cross-functional teams including Quality, Regulatory, Supply Chain, and Clinical Operations; drive continuous improvement, innovation, and organizational scalability for growth. Requirements: 20+ years in biotech/pharma, with extensive experience in biologics (monoclonal antibodies), commercial manufacturing, process development, validation, and lifecycle management; proven success in supporting regulatory filings (BLAs, supplements) and managing CMOs/CDMOs; advanced scientific degree (Ph.D. preferred). HighValue: biologics (mAbs), commercial-stage, late-stage development, process validation, global CMC regulatory expertise, leadership of technical operations teams, involvement in regulatory inspections, and external manufacturing oversight. WorkSetup: not specified; likely hybrid or on-site.