Operations Supervisor

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three RD sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. 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). 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 an Operations Supervisor as part of the Technical Operations team based in Raritan, NJ . Role Overview The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule. Shift Options Available: Wed–Sat, 2nd Shift Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks. Work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance. Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor. Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses. Color Perception both eyes 5 slides out of 8. Requirements Bachelor’s degree in Science, Engineering or related field or equivalent experience required. A minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, quality, or engineering is required. Excellent communication and organizational behaviors skills are required. Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required. Availability to work in a day shift (1st or 2nd shift) is required. Knowledge of cGMP regulations and FDA g ... (truncated, view full listing at source)