Sr. Manager, QC Microbiology

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 Sr. Manager, QC Microbiology as part of the Quality team based in Raritan, NJ.

The Sr. Manager, QC Microbiology, is an exempt level position with responsibilities for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. The role develops and implements long-term strategies and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities.

• Ensuring adequate training (skills-based, cGMP and safety) of people leaders and associates within the department.

• Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.

• Manage and support Investigation of laboratory non-conformances (events, deviations, and invalid assays).

• Maintenance, calibration and qualification of laboratory instruments and equipment.

• Test method verification, qualification, validation and/or transfer activities in the QC Micro laboratories.

• <span style="font-size: 12pt; font-family: arial,