Company Information
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking QC Investigations Supervisor as part of the Quality Control team based in Raritan, NJ.
Role Overview
The QC Investigations Supervisor is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Key Responsibilities
- 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.
- Ability to respond with a high degree of urgency to departmental and cross functional needs and requests.
- Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
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 law.
Legend Biotech maintains a drug-free workplace.