Sr Manufacturing Technical Expert II

Role: Lead the design, startup, and operational management of Gilead’s new biologics drug substance manufacturing facility in Foster City, CA, specializing in biologics drug substance single-use GMP manufacturing. Responsibilities: oversee facility design input, execute GMP startup activities, troubleshoot operations, develop validation protocols, and implement process improvements; provide technical leadership on digital manufacturing, automation, and quality compliance; ensure readiness for regulatory inspections, author GMP documentation, and lead CAPA investigations. Requirements: BS in Science or Engineering with 8+ years of deep technical experience in biologics drug substance manufacturing, including on-the-floor GMP operations, single-use technology expertise, process validation, and knowledge of health authority standards (FDA, EMA, ICH). Preferred: experience with automation systems (e.g., MES, SAP), digital solutions, AI applications in manufacturing, and leadership in cross-functional teams. HighValue: biologics (cell culture CHO processes), GMP cGMP facility startup and operation, process validation, digital manufacturing and AI integration, regulatory compliance, and team leadership. WorkSetup: hybrid onsite in Foster City; travel not specified.