Associate Director, Technical Operations - Small Molecule Drug Substance
Merck
August 27, 2026
Full-time
Remote friendly (Elkton, VA)
Worldwide
Operations
Role: Associate Director, Technical Operations β Drug Substance, leading technical activities for API manufacturing at a small molecule biopharma site. Responsibilities: oversee process support, technology transfer, validation, and ongoing production; drive process improvements, troubleshoot manufacturing issues, ensure cGMP compliance, and support regulatory inspections; collaborate across functions including Engineering, R&D, Quality, and Manufacturing; lead and develop technical teams. Requirements: BSc/BEng/Masterβs in Chemistry or Chemical Engineering; 10+ years in API process development or manufacturing; expertise in process chemistry, scale-up, validation, and process systems; knowledge of cGMP, regulatory expectations, and deviation management. Preferred: experience with capital projects, CQV, and facility startup; strong problem-solving and leadership skills. HighValue: small molecule APIs, process development, manufacturing, validation, cGMP regulation, cross-functional engagement, site startup, 10% travel. WorkSetup: not specified; travel required.