Investigator II

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 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 reasoning, and problem-solving skills when evaluating complex quality events.
Analyze investigation and deviation trends to identify recurring issues, systemic risks, and opportunities for proactive process improvements.
Author clear, concise, and scientifically justified investigation reports suitable for regulatory review and inspection scrutiny.
Provide guidance and technical support to junior investigators and cross-functional teams on investigation methodologies and root cause analysis techniques
Recognize and escalate critical quality issues appropriately while ensuring timely communication with stakeholders and leadership.
Utilize electronic quality management systems (eQMS) to manage investigations, CAPAs, effectiveness checks, and associated quality records.
Requirements
BS/BA in engineering, science, or related field.
4-6 years of cGMP experience within biotechnology, biopharmaceutical, pharmaceutical, or other regulated industries, and/or 2-4 years of quality investigation experience. Experience in engineering, facilities, equipment, validation, or quality systems is preferred. A combination of relevant industry, technical, and investigation experience will be considered. Demonstrated ability to independently manage multiple concurrent investigations while consistently meeting quality and timeliness expectations.
Demonstrated proficiency in conducting moderate- to high-complexity investigations, performing risk assessments, identifying root causes, and developing effective corrective and preventive actions (CAPAs).