Principal Scientist, Analytical Biochemistry
MedImmune

Stephan O. Krause has a PhD in analytical biochemisry from the University of Southern California.  He has held leading roles for validation and quality for several biopharmaceutical firms.  He is currently MedImmune's subject matter expert for analytical qualification, validation, and transfers and the global specification coordinator for CTMs.  Before MedImmune, Stephan was a director of QA and QC operations for CTM manufacturers in California.  Prior to this, he was manager of QA/QC Technical Services at Bayer's (commercial) Biologics/Biotech Division.  As Bayer's primary external liaison for laboratory operations, he impacted industry standards by working closely with regulatory and industry representatives.  Stephan has published many articles on quality and validation in industry journals in the US, Europe, and Asia.  His book on risk-based method validation strategies (PDA/DHI Publications, April 2007) won the PDA Distinguished Author Award in 2008.  Stephan often serves as session chair and lecturer at major conferences worldwide.  He is a member of several Editorial and Scientific Advisory Boards.  He is PDA's task force leader for Analytical Method Validation and a PCMO task force leader for CTM manufacturing.