QC, Investigations Specialist II​/III

Role Overview

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

We are seeking a QC, Investigations Specialist II/III as part of the Quality team based in Raritan, NJ
.

Mon‑Fri, 1st Shift

• Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
• Review/complete routine CAR‑T manufacturing nonconformance/deviation investigations.
• Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories.
• Provide recommendations for the improvement of processes by working cross‑functionally with multiple stakeholders.
• Work closely with management to propose/execute improvements through the change management system.
• Respond with a high degree of urgency to departmental and cross‑functional needs and requests.
• Report/monitor metrics on non‑conformance investigations and corrective and preventive actions (CAPA).
• Perform tasks in a manner consistent with the safety policies, quality systems and cGM requirements.
• Work collaboratively with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.

• Minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
• Minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry.
• Experience in a Quality Control setting is preferred.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products is required.
• Knowledge of Good Tissue Practices is required.
• Detailed knowledge of CAR‑T QC test methods and related equipment is preferred.
• Excellent written and oral communication skills are required.
• Candidates must accommodate shift schedule, including routine weekend and evening work as required by the manufacturing process.
• Candidates must accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• Highly organized, capable of working in a team environment with a positive attitude under some supervision.
• Comfortable speaking and interacting with inspectors.
• Occasional travel to partner sites in NJ or PA may be required.
• Up to 10% domestic or international travel as business demands.

The anticipated base pay range is: $75,972 USD - $99,713 USD

We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance as well as a 401(k)‑retirement plan with company match that vests fully on day one.

Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.

We also provide commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Legend Biotech maintains a drug‑free workplace.