Mihaela is a chemist with a PhD in pharmaceutical chemistry from the Ruprecht-Karls University of Heidelberg, Germany. After completing post-doctoral research at the University of Heidelberg’s Institute for Pharmacy and Molecular Biotechnology, she joined the Institute for Reference Materials and Measurement at the Joint Research Centre (JRC) of the European Commission, where she focused on developing and certifying reference materials for quality control in bioanalysis. In 2013, she became a Scientific Programme Manager at the European Directorate for the Quality of Medicines & HealthCare (EDQM), contributing to the development of European Pharmacopoeia documentary standards for biotherapeutics (including monoclonal antibodies), mRNA vaccines, and plasma-derived medicinal products. She was actively involved in the early work of the Analytical Quality by Design Working Party, helping shape its strategic direction. Since 1 January 2025, she has taken up the role of Head of Section for the Biological Standardisation Programme at the EDQM.