Sr Manufacturing Technical Expert II

Role: Lead the design, startup, and operation of Gilead's new biologics drug substance manufacturing facility in Foster City, CA, with a focus on single-use GMP technologies. Responsibilities: oversee startup readiness, support GMP execution, develop validation strategies, contribute to facility and equipment design, and lead digital manufacturing initiatives. Act as a technical first responder during campaigns, ensure compliance with cGMP, author and review GMP documentation, and drive process improvements while applying innovative digital and AI solutions. Collaborate across cross-functional teams—including engineering, quality, automation, and regulatory—to ensure successful facility commissioning and ongoing operations. Requirements: BS in Science or Engineering with at least 8 years' experience in biologics drug substance manufacturing, especially with single-use technologies, process validation, and GMP compliance. Deep technical expertise in bioprocessing, equipment design, automation, and digital manufacturing systems (e.g., MES, ERP). Experience with cell banking, bioprocess development, and regulatory inspections (FDA, EMA, ICH). Demonstrated leadership in technical teams, strong collaboration skills, and a builder’s mindset. High-value: biologics (cell/viral vectors, monoclonal antibodies), cGMP manufacturing, process validation, digital tech transfer, and AI integration in biopharma manufacturing. Work setup: hybrid onsite in Foster City, with leadership in startup and ongoing operations.