Zoltan Sümeghy

Dr. Zoltan Sümeghy holds a Ph.D. in Biochemistry from the Technical University of Budapest, where he previously studied Biochemical Engineering. Dr. Sümeghy started his career as a Lab Head at the Biotechnology Research Department, where he was responsible for USP development for all cell culture projects including scale-up, as well as for establishing the first development and GMP facility for cell cultures at Sandoz. From 1994 till 1999, Dr. Sümeghy worked for Sandoz/Novartis AG as the Plant Manager USP for Basiliximab. During this period, he was responsible for the installation and qualification of the former production plant in Basel for Basiliximab and gained extensive experience in manufacturing, process validation, and Health Authority inspections (FDA, EMEA, KFDA, Swissmedic, etc.).

From 1999 till 2004, he was operating as a Head USP production for marketed proteins at Novartis Pharma AG. Starting from 2004, Dr. Sümeghy has held a variety of roles at Novartis BPO-Basel, where he was engaged in production site for removing an FDA Warning Letter, production site solving contamination issues, EPO Transfer and scale up from CMO to NVS production site (Biosimilar), etc.

From 2009, Dr. Sümeghy acted as a Head of non-GMP Pilot Plant at Novartis Biologics Process Development and was responsible for the process scale-up and process transfer to the clinical manufacturing site for early phase development projects, as well as for external collaborations with CDO/CMO-s from a technical perspective. In 2014 he was promoted as a Senior Fellow at Novartis Cell and Gene Therapies. Till 2017 he acted as Head Technical Support for an external collaboration (lentiviral vector process development and manufacturing) including advising the CMO for process characterization, process validation, and for preparing the required documents for the Kymriah BLA submission. Starting from 2017, Dr. Sümeghy acts as an independent consultant providing support in the aria of pharma, biotechnology, vaccines, cell and gene therapies.