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, specializing in single-use GMP processes. Responsibilities: oversee facility design input, execute GMP startup activities, ensure operational readiness, lead manufacturing campaigns, develop process validation, and implement digital manufacturing solutions; provide technical guidance across cross-functional teams; ensure compliance with cGMP, QA, and health authority standards; and mentor staff. Requirements: BS in Science or Engineering with at least 8 years of deep technical experience in biologics drug substance manufacturing, including hands-on GMP plant floor experience, expertise with single-use technologies, process validation, and manufacturing data systems (e.g., MES, ERP). Preferred: experience with process automation, digital innovation (AI), and regulatory interactions. High-Value: biologics (likely CHO-based), cGMP biologics manufacturing, process startup/validation, process automation, digital manufacturing, regulatory compliance, and team leadership in a biologics setting. Work setup: hybrid in Foster City, with a focus on both strategic design and hands-on execution.