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. * 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 * Knowledge of and experience with relevant regulations and guidance documents (AMG, AMWHV, EU-GMP/GDP)
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