Investigations Supervisor

Role: Investigations Supervisor within Legend Biotech's Manufacturing & Supply team, focusing on CAR-T cell therapy production. Responsibilities: lead investigation efforts to identify root causes of deviations, assess product quality impact, support investigations, track corrective actions, and implement process improvements. Serve as SME for regulatory audits (FDA/EU), and ensure compliance with cGMP standards. Qualifications: BS/BA in engineering or sciences; 6+ years relevant experience, especially in complex investigations, with knowledge of cGMP regulations and regulatory audit experience. High-Value: focus on cell therapy manufacturing (CAR-T), cGMP compliance, root cause investigations, and process improvements. Work setup: based in Raritan, NJ, with exposure to biological materials and hazardous chemicals.