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Our client is on a mission to revolutionize healthcare by combatting life-threatening diseases with groundbreaking biotechnology. Situated in the vibrant heart of New Jersey, their global influence extends far and wide as they pioneer advanced cell therapies across various technology platforms. From autologous and allogeneic chimeric antigen receptor T-cell therapies to T-cell receptor (TCR-T) and natural killer (NK) cell-based immunotherapy, innovation drives every aspect of their work.
With research and development sites spread across the globe, they tirelessly pursue the discovery of safe, effective, and groundbreaking therapies for the benefit of patients worldwide.
In a monumental step towards their goal, they have forged a dynamic global collaboration with a Belgian player. This partnership is dedicated to the development, production, and commercialization of ciltacabtagene autoleucel (cilta-cel), with the aim of redefining immunotherapy in the treatment of multiple myeloma.
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 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 requirements. You will work in a team based, cross-functional environment to complete production tasks required per schedule and drive continuous improvement of manufacturing operations leveraging own observation as well as input of junior team members. 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 Facility in Ghent and report to the Operational Manager, Europe.
We are seeking candidates with a passion for biotechnology and a minimum of 1 year of hands-on experience within a aspetic environment. Knowledge of aseptic techniques, strong analytical skills, and a can-do attitude are essential. Fluency in English and Dutch, along with proficiency in Microsoft Office tools, is required. Additionally, weekend and shift work should pose no problem for you.
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