Simone joined Aroa Biosurgery’s management team over 6 years ago. She brings extensive expertise in biological product manufacture, with more than 30 years of practice in various technical fields. She was previously a senior manager and head at Baxter Healthcare Austria (Baxter Innovations, now Takeda, Biopharmaceuticals) where she developed and managed operations, process transfer, and contributed to process development. Her proven skills as a leader of international and cross-functional teams and outstanding contribution to successful project completion has been international acknowledged in 2007 for the generation of a continuous cell line, 2010 for the development of a bio-improved human recombinant activated factor and 2011 for tech transfer, planning and construction support for commissioning of a vaccine plant in Japan with the Bioscience Research and Development Award of Baxter Healthcare. Simone is experienced in quality requirements and systems and has successfully managed inspections from authorities (e.g. FDA, PMDA, ANVISA, European Governments). She holds qualification as an auditor for products manufactured from biological source materials and supported regulatory product licensure for the US, Australian, New Zealand, Japan and EU market. Prior to this role Simone worked for biotech start-up Mologen (Germany) and was a Scientific Assistant at the University of Amsterdam (The Netherlands) and University of Oldenburg (Germany) on the basis of different programs of the European Union (Biogeochemistry of Coastal Lagoons Eutrophication), and responsible for implementation and maintenance of laboratories on research vessels in the European Marine Waters. She has degrees in Public Health and Laboratory Technology.