Senior Biologics Manufacturing Technical Expert

Role: Lead technical expert in biologics drug substance single-use GMP manufacturing, responsible for designing, startup, and operational management of Gilead's new Foster City biologics facility. Responsibilities include overseeing GMP startup, supporting equipment and process validation, providing manufacturing input to facility design, and leading ongoing operations while ensuring compliance, quality, and efficiency. The role requires direct floor presence for hands-on execution, troubleshooting, and continuous improvement. Collaboration spans cross-functional teams in engineering, quality, automation, and technical development, with active involvement in digital innovation and AI application. Key aspects involve GMP documentation, regulatory interactions, and implementing innovative manufacturing strategies. Qualifications: BS in Science or Engineering with ≥6 years' experience in biologics drug substance manufacturing, particularly in single-use technologies. Deep expertise across at least three technical dimensions such as process design, validation, automation, quality assurance, or risk management is expected. Leadership in GMP operations, facility startup, or process automation preferred. High-value biopharma specifics: biologics (likely CHO-based), cGMP compliance, process validation, regulatory inspection readiness, and digital manufacturing tools. The position offers a hybrid work setup with a salary range of $146,540–$189,640, plus bonuses, stock incentives, and benefits. Emphasis on leadership, collaboration, innovation, and regulatory knowledge in a fast-paced, compliance-driven environment.