Sr Manufacturing Technical Expert II

Role: Lead Biologics Drug Substance Single-Use GMP Manufacturing at Gilead’s new Foster City facility, overseeing design, startup, and ongoing operations of the biologics manufacturing plant. Responsibilities: direct technical execution during GMP startup, support facility and equipment design input, lead process validation, ensure compliance with cGMP standards, and implement operational improvements. Also, provide leadership, coaching, and cross-functional collaboration across engineering, quality, and automation teams, emphasizing digital innovation and process optimization. Requirements: BS in Science or Engineering with a minimum of 8 years’ deep technical experience in biologics drug substance manufacturing, particularly with single-use technologies, process validation, and GMP compliance. Deep expertise in bioprocess design, automation, digital manufacturing, and regulatory standards such as FDA, EMA, ICH. Preferred: experience with process automation systems (e.g., MES, SAP), AI applications in manufacturing, and team management. High-Value: biologics (likely CHO-based), cGMP manufacturing startup, process validation, digital solutions, and regulatory interactions. Work setup: hybrid in Foster City, CA, with leadership responsibilities spanning design, startup, and operational phases.