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 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).
• Experience conducting product impact assessments and applying risk management principles in support of quality and disposition decisions.
• Experience reviewing and interpreting manufacturing, engineering, maintenance, calibration, environmental monitoring, and validation records to support investigation activities.
• Excellent technical writing and documentation skills, with the ability to independently author clear, concise, scientifically sound, and inspection-ready investigation reports.
• Working knowledge of electronic Quality Management Systems (eQMS)
• Demonstrated ability to effectively collaborate and influence crossfunctional teams in resolving complex quality events.
• Strong Ability to present investigation outcomes and respond to internal audit and regulatory inspection inquiries with minimal oversight.
• Technical knowledge of biologics, cell therapy, gene therapy, or pharmaceutical manufacturing processes.
• Proficiency in science- and risk-based decision-making and structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
• Working knowledge of cGMP regulations, quality systems, and data integrity principles.
• Experience supporting regulatory inspections, audits, and health authority inquiries.
• Strong technical writing, communication, and presentation skills.
• Ability to independently manage multiple moderate- to high-complexity investigations.
• Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).

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