In this role, you will have quality oversight of the latest approved biological product at Otsuka, ensuring manufacturing, packaging, labelling, storage and transport is in accordance with regulatory expectations, applicable GMP/GDP standards for biologics and corporate requirements. You will bring Biologics Quality Assurance support, including oversight of upstream and downstream manufacturing processes, by collaborating with other Otsuka affiliates based in the US, Japan and relevant CMOs in Germany and the US. * Minimum of 5 years' proven experience in GMP manufacturing of biologics, including both upstream (cell culture, bioreactor) and downstream (purification, filtration, formulation) processes, gained in either Quality Assurance or Manufacturing
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