About the Role
As CAR-T Operations Expert, you will be part of the manufacturing operations team responsible for production of CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment. You will lead and perform multiple units within the CAR-T process operations (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. As CAR-T Operations expert, you need to build and maintain smooth and strong collaborations with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse 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 junior operators on the production floor. You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.
Bachelor’s or Master’s degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required.
A minimum of 3 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
A minimum of 3 years experience in aseptic techniques in clean rooms
Prior experience in manufacturing, quality, or engineering is required
About the Company
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 R&D 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 Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
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