Assoc. Dir - Large Molecule External Manufacturing Technology, Network & Viral Lead
Merck
September 29, 2026
Full-time
Remote friendly (Millsboro, DE)
Worldwide
Operations
Role: Associate Director leading global external manufacturing for large molecule (LM) drug substances in animal health, focusing on viral products and network transfers. Responsibilities: manage LM drug substance portfolio across CMO network, oversee tech transfer, process development, process improvement, troubleshooting, and lifecycle management; lead supplier technical management, conduct audits, and support global sourcing; ensure timely delivery, manage deviations, and drive innovation to optimize processes and reduce costs. Collaborate with cross-functional teams including procurement, Quality, R&D, and manufacturing; lead technical due diligence, develop technical packages, and support regulatory strategies. Requirements: Bachelor's in Biochemistry, Bioprocess Engineering, or similar; 10+ years in biopharma, with at least 5 years in LM process development, including viral vaccines and monoclonal antibodies; strong project management, leadership, and communication skills; experience with global CMOs, process scale-up, and regulatory compliance (US/EU). Preferred: PhD, Six Sigma/PMP certification, deep process troubleshooting expertise, and CMO audit experience. High-Value: biologics and viral vaccine development, process transfer for in-line supply, cross-continental coordination, and regulatory strategy expertise. Work setup: hybrid with 15-20% travel.