Brian Nunnally
Brian K. Nunnally, Ph.D. is 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, the journal 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 of two United States Pharmacopeia (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 Affairs, 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.
Key Areas of Research
Process Validation, Bioanalytical Chemistry, Pharmaceutical Quality Control, Stability, Vaccines
Professional Affiliations
American Chemical Society California Separation Society
Education
B.S. (Chemistry) with Honors from South Carolina Honors College, University of South Carolina
B.S. (Marine Science) with Honors from South Carolina Honors College, University of South Carolina
Ph.D. in Chemistry, Duke University
Awards
Journal of Validation Technology Paper of the Year, 2009
Technical Promotion to Research Scientist, Eli Lilly and Company, 2002
Quality Advocate award, Eli Lilly and Company, 2000
Hercules Incorporated/Werner C. Brown Summer Fellowship, 1997
NIH Molecular Biophysics Fellowship, Duke University, 1994
NSF Summer Research Fellowship, Florida State University, 1993
South Carolina Honors College Research Fellowship, University of South Carolina, 1992
Carolina Scholar, University of South Carolina, 1990
Eagle Scout, 1987
Published Articles
Books:
Prions and Mad Cow Disease, Edited by B.K. Nunnally and I. Krull, Marcel-Dekker, 2003.
Six Sigma in the Pharmaceutical Industry: Understanding, Reducing and Controlling Variation in Pharmaceuticals and Biologics, J.S. McConnell and B.K. Nunnally, Taylor and Francis, 2007.
Selected Articles:
B.K. Nunnally, J.S. McConnell, and D.F. Nunnally, Biopharm Int., 2008, 21(6): 66-72.
Case Study: Reduction of Analytical Variability in a Pharmaceutical Research and Development Laboratory, B.K. Nunnally, A. Johnson, and R. Kaiser, Journal of Validation Technology, 2009, 15(1): 77.
The Use of Variance Components Analysis to Determine Sources of Variation for Vaccine Drug Product Assays, B.K. Nunnally, Journal of Validation Technology, 2009, 15(3): 78.
Design and execution of a shipping qualification for a vaccine drug substance, J. Tull, B.K. Nunnally, Journal of Validation Technology, 2010, 16(1): 84.
