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:
鈥� Review technology transfer documents and conduct risk assessment prior to process implementation;
鈥� Definition of process development plans for purification accordingly with the risk-assessment evaluation and the Quality by Design (QbD) initiative;
鈥� Definition of the relevant product analytical characterization and process characterization;
鈥� Writing of SOPs and batch production reports;
鈥� Hands-on operation of purification equipments for microfiltration, ultrafiltration and chromatography (脛KTA ...
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