Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.
Legend Biotech is seeking a Investigator I/II as part of the Technical Operations team based in Raritan, NJ.
Role Overview
Investigator II independently leads and manages moderate- to high-complexity quality investigations related to manufacturing, engineering, facilities, equipment, and validation systems. This role assesses product quality, patient impact, and regulatory significance using a science- and risk-based approach; performs comprehensive root cause analyses; develops robust investigation reports, CAPAs, and effectiveness strategies; and ensures compliance with site procedures, regulatory requirements, and data integrity standards. Investigator II collaborates cross-functionally with subject matter experts and business partners to resolve complex quality events, support timely product disposition decisions, and drive continuous improvement initiatives.
Key Responsibilities
Independently lead end-to-end investigations related to manufacturing, facilities, engineering, equipment, validation, and other cross-functional quality events.
Collect, review, and evaluate supporting investigation data, including manufacturing records, equipment logs, environmental monitoring data, maintenance records, validation documentation, and historical quality events.
Conduct investigations related to facility and environmental monitoring excursions.
Demonstrate the ability to prioritize and dynamically adjust workload based on business needs, product impact, and organizational priorities.
Perform comprehensive risk and impact assessments related to product quality, patient safety, data integrity, and regulatory compliance.
Timely Prioritize investigation activities and timelines to support patient batch disposition and release decisions using a robust risk-based approach and impact assessment, leveraging the required SMEs.
Conduct detailed root cause analyses using various structured methodologies.
Develop and own CAPA investigations; ensure timely closure and proper effectiveness checks.
Drive and owns investigation meetings, cross-functional alignments and support resolution of complex quality events.
Rapidly learn and develop a strong understanding of new manufacturing, engineering, validation, and facility processes to support effective and efficient investigations.
Collaborate closely with SMEs, Quality leads, and cross-functional stakeholders to ensure investigations are thorough, scientifically sound, and inspection-ready.
Support internal audits and regulatory inspections, including presenting investigation, findings, and conclusions to auditors and inspectors.
Ensure all investigations are completed in accordance with established quality standards, regulatory requirements, and defined timelines.
Contribute to continuous improvement initiatives related to investigation processes, documentation practices, systems, and quality tools.
Demonstrate strong analytical thinking, critical…