CMC - Drug Product DevelopmentInjectable Formulation Development

Drug Product Production SupportAseptic Fill & Finish processesMy responsibilities at Bavarian Nordic included planning the individual batch productions weeks in advance to ensure timely and correct delivery of GMP items, SU Technologies, and API. I was responsible for the LIMS and ERP system for the vaccine production in a FnF facility established in 2019 in Kvistgård. My time was split between day-to-day support for formulation, filling, inspection and packaging, and driving projects and change controls to optimize the individual processes and overall flow of the production line. A large part of my position was identifying areas of improvement when providing support and afterwards performing root-cause analysis, trouble-shooting, SPS, handling deviations, executing CAPAs as well as performing validations through IQ/OQ/PQ when implementing new procedures or changing existing ones.