Brian K. Nunnally, Ph.D. is the Director of Global Stability at Biogen. Previously, he was the Global Regulatory CMC lead for two marketed products. Prior to this, he was in charge of Process Validation for the Pfizer, Sanford, NC site. He is a co-author, with John McConnell, of the book Six Sigma in the Pharmaceutical Industry [2007, Taylor & Francis]. Dr. Nunnally has authored numerous publications in the field of analytical chemistry and operation excellence and has given lectures in a variety of subjects. He is an assistant editor of the Journal of Validation Technology, Chromatographia, Analytical Letters, and a member of the Analytical Chemistry Division of the American Chemical Society and the Society for Applied Spectroscopy. Dr. Nunnally is a member the United States Pharmacopeia (USP) 2010-2015 Monograph 2 Expert Committee and was a member of two USP 2005-2010 Expert Committees (Reference Standards and Biotechnology and Biologics: Vaccine and Virology). Dr. Nunnally received two B.S. degrees (1994) from South Carolina Honors College, University of South Carolina, Columbia, and a Ph.D. degree (1998) in chemistry from Duke University, Durham, North Carolina. Prior to taking the Process Validation position, Dr. Nunnally worked in TO&PS Regulatory Affairs. He was responsible for leading the Sanford site's contributions to one of the biggest filings in pharmaceutical history. Prior to joining TO&PS Regulatory, Dr. Nunnally was the Associate Director for GMP Operations in Vaccine Analytical Development at Wyeth. The group he led was responsible for all Reference Standards, Stability, GMP Testing, and Validation for the vaccine candidates Wyeth was developing. Dr. Nunnally has previously worked for Eli Lilly and Company. While at Lilly, he was responsible for leading a Quality Control laboratory devoted to new method development, method optimization, analytical testing for process validation, and analytical testing for manufacturing investigations.