Investigator I/II
The Investigator I/II position at Legend Biotech US is integral to the Technical Operations team in Raritan, NJ. This role focuses on leading and managing quality investigations related to manufacturing, engineering, facilities, equipment, and validation systems. Legend Biotech is a global biotechnology company dedicated to developing advanced cell therapies for life-threatening diseases.
Key responsibilities include independently conducting investigations into quality events, analyzing data from various sources such as manufacturing records and equipment logs, and performing risk assessments to evaluate product quality and patient safety. The role also involves developing and implementing corrective and preventive actions (CAPAs), collaborating with cross-functional teams to resolve complex quality issues, and supporting internal audits and regulatory inspections.
Candidates should possess a BS/BA in engineering, science, or a related field, with 4-6 years of cGMP experience in biotechnology or pharmaceutical environments. Experience in quality investigations, engineering, facilities, equipment, or validation systems is preferred. Strong analytical, problem-solving, and technical writing skills are essential, along with proficiency in electronic Quality Management Systems (eQMS) and a solid understanding of cGMP regulations.
The compensation for this role ranges from $72,791 to $102,705 annually, depending on experience and qualifications. Benefits include medical, dental, and vision insurance, a 401(k) retirement plan with company match, paid parental leave, and a comprehensive paid time off policy. Additional perks encompass flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, and various supplemental plans.
Legend Biotech fosters a collaborative and innovative work environment, offering opportunities for professional growth and development. The company is committed to advancing cell therapy technologies and provides employees with the chance to contribute to transformative treatments for serious diseases.