Manufacturing Changeover Manager - Drug Substance
Merck
September 29, 2026
Full-time
On-site
Elkton, VA
Operations
Role: Manufacturing Changeover Manager for Drug Substance/API at a small molecule biopharma site, overseeing turnaround activities to support efficient campaign transitions. Responsibilities: lead planning, coordination, and execution of turnarounds, ensuring safety, compliance, and operational excellence; develop standardized processes; coach cross-functional teams; monitor performance metrics; drive continuous improvement and operational discipline; support daily operations. Requirements: Bachelor's degree in Engineering, Chemistry, or related field; 5+ years in GMP pharmaceutical or biotech manufacturing; experience leading changeovers, turnarounds, or campaign transitions; strong leadership, planning, and lean principles skills; knowledge of regulated GMP environments, safety, and compliance. Preferred: experience in small molecule manufacturing, process improvement, and cross-functional stakeholder management. High-Value: GMP manufacturing, small molecule API operations, turnaround leadership, regulated compliance, process optimization, team development. WorkSetup: onsite with 10% travel.