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Brussels Area, Belgium Belgium

Downstream Process Development Engineer

Medical / Health Care / Pharmaceuticals

I develop purification process for vaccines and gene therapy vectors to be transferred to GMP manufacturing as part of our CMO activity. My responsibilities include: • Review technology transfer documents and conduct risk assessment prior to process implementation; • Definition of process development plans for purification accordingly with the risk-assessment evaluation and the Quality by Design (QbD) initiative; • Definition of the relevant product analytical characterization and process characterization; • Writing of SOPs and batch production reports; • Hands-on operation of purification equipments for microfiltration, ultrafiltration and chromatography (ÄKTA ...