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Director, Engineering - Technical Operations

Merck
August 25, 2026
Full-time
On-site
Wilmington, DE
Operations
Role: Serve as Technical Operations Director overseeing manufacturing and technical functions for a biologics facility producing potent drugs including ADCs. Objectives: lead site operations, develop strategic manufacturing roadmap, ensure compliance, and support clinical and commercial product supply. Responsibilities: manage technical teams supporting process transfer, validation, new product commercialization, facility startup, and continuous improvement; partner with R&D, Quality, Supply Chain, and Regulatory to ensure product quality, compliance, and timely delivery; develop budgets, talent, and operational strategies; oversee process validation, investigations, CAPA, and technology advancements. Requirements: Bachelor's in Engineering, Science, or related field with 12+ years industry experience (or advanced degrees with proportionate experience); minimum 6 years leadership in biologics manufacturing, including potent drug substances and ADCs; expertise in GMP, facility startup, process transfer, validation, and regulatory inspections; strong project management, financial, and cross-functional collaboration skills. Preferred: experience with ADC commercialization, analytical methods, and pharmaceutical manufacturing at pilot/scale-up or commercial levels. High-Value: biologics, ADCs, potent drug substances, process validation, GMP compliance, clinical to commercial transition, cross-functional leadership, global regulatory readiness. WorkSetup: onsite with ~10% travel.