QC Microbiology Lead

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 a QC Microbiology Lead as part of the Quality team based in Raritan, NJ. Role Overview The QC Microbiology Lead is an exempt level position with responsibilities for supervising 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. Key Responsibilities Ensuring adequate training (skills-based, cGMP and safety) of associates within the department. Raw material, in-process, environmental/utility, and product release testing. Scheduling of daily activities for personnel. 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 laboratories. Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing. Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations. Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements. Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs. Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision. Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary. Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses. Color Perception both eyes 5 slides out of 8. Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell ... (truncated, view full listing at source)