Head of CMC Strategy Biologicals at Boehringer Ingelheim
Dorothee Ambroisus holds a PhD in Biology / Biochemistry and has > 25 years’ experience in the field of research and development of biotherapeutical Medicines. Beyond her scientific background and development knowledge she has held numerous senior management positions in 3 different global pharmaceutical companies. Currently, she is responsible for CMC Strategies for Biologicals driving strategic CMC development concepts as well as comparability strategies for Biologicals at all development stages. From 2010 to 2015 she was the SVP for Global Bioprocess & Pharmaceutical Development at Boehringer Ingelheim responsible for drug substance, drug product & device development as well as clinical supplies (phase I/II/III) and tech transfer to the large scale production facility within the Biopharmaceutical Business Unit. The global process development organization was supporting all BI biological projects as well as the 3rd party projects and she was heading with > 700 employees at 4 different sites: Vienna (Austria) for Microbial Process Development and Biberach (Germany), Fremont (US) and Shanghai (China) for Mammalian Process Development In addition she was driving the global technology program. She joined Boehringer Ingelheim in 2003 as Head of Downstream Development responsible for DSP process development, tech Transfer and clinical supplies. Dorothee started her industrial carrier in 1989 at Boehringer Mannheim, Biotech Research Center in Penzberg and spent 8 years at various research positions in discovery and development of novel therapeutic protein medicines. Since 1997, she was at Roche Diagnostics GmbH and spent 6 years as Head of Biochemistry and Protein Science in research and development of mainly NBEs but also NCE. She is a member of the organization committee for the “Halle Conference for Protein Production”, member of 3 different academic councils, has written a book chapter, several publications, developed new trademark protected technology platforms and holds many patents in the area of Biotechnology.