QA, Shop Floor Specialist 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 QA Shop Floor Specialist as part of the Quality team based in Raritan, NJ.

The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

• Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks/internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Review of all documentation, in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs)
• Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
• Support batch review & material release in SAP for In-house reagents.
• Support Floor Spot-check, audit trail review.