Paula has over 20 years of experience in biopharmaceutical and pharmaceutical process development and quality, 25 publications and 4 process patents. Dr. Shadle received her B.S. and Ph.D. in biochemistry at the University of California, and was a postdoctoral fellow of the Max-Planck Institute for Biophysical Chemistry in Germany. She worked at Chiron Corporation, Scios Inc., GlaxoSmithKline plc, and Bayer Corporation before founding Shadle Consulting in 2001. At GSK she directed downstream process development, then biopharmaceutical quality operations, overseeing QA, QC, analytical methods and validation. She created the division’s quality strategic plan, helped design commercial facility QC laboratories, and transferred three biopharmaceutical processes from development to manufacturing site. At Bayer Corporation, Dr. Shadle was director of quality control of marketed products.  She has taught in adult education for the University of Wisconsin, the Parenteral Drug Association (PDA), Product Quality Research Institute (PQRI), and the Institute for International Research.  Dr. Shadle received the 2000 Judith Pool Award for excellence in teaching and mentoring from the American Women in Science.  She was an organizing committee member for the 2001-2003 PDA-FDA Meeting in Washington, D.C. and moderated sessions on GMPS during development, CAPA, QC laboratories and viral clearance.  She is a member of PDA, ISPE, and ASQ, and on the editorial board of BioPharm International.  In 2003, she became chapter president of the East Bay Chapter of AWIS (American Women in Science), an organization that mentors and supports women in the sciences.