Andrea Bauer

Andrea Bauer, Ph.D. RAC has extensive work experience in the pharmaceutical industry. Andrea is currently the Senior Director of Drug Product Development at Scorpion Therapeutics, a position they have held since January 2023.

Prior to their current role, Andrea served as a Member of the Board of Directors for the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) from September 2012 to January 2023. Andrea was also a Member of the IQ Consortium, participating in their DPLG and Working Groups from January 2012 to January 2023.

Andrea's previous experience includes working at Sunovion Pharmaceuticals (formerly Sepracor) as the Head of Formulation Development and Senior Director from February 2003 to January 2023. In this role, they were responsible for formulation, process development, tech transfer, and CMC project management for various drug product types.

Before joining Sunovion Pharmaceuticals, Andrea worked at Syntonix Pharmaceuticals (now Biogen Idec) as a Staff Scientist II from May 2001 to February 2003. Andrea'sresponsibilities included setting up a formulation/analytical/QC laboratory and conducting studies on protein products for inhalation and oral delivery.

Andrea's career started at Primedica (Genzyme Transgenics Corporation) as a Scientist II from April 1998 to May 2001. In this position, they focused on formulation development and scale-up of inhalation drug products and worked with novel delivery devices.

Andrea also gained valuable research experience as a Postdoctoral Researcher at Boehringer Ingelheim from 1997 to 1998.

Throughout their career, Andrea has been involved in CMC regulatory affairs, authored/reviewed submissions for NDAs, INDs, and PASs, and obtained a regulatory affairs certificate (RAC) in 2010.

Andrea Bauer, Ph.D. RAC completed their education at the University of Munich, Germany. Andrea obtained a Bachelor of Pharmacy (B.Pharm.) degree from 1989 to 1993. Following this, they pursued a Ph.D. in Pharmaceutics from 1993 to 1997. Additionally, they have obtained certifications in Regulatory Affairs, including the RAC-US certification from the Regulatory Affairs Certification Program in 2010.