Brian K. Nunnally

Brian K. Nunnally, Ph.D. is the Head of Quality Control for Seqirus. Being the best quality control unit drives his passion. Prior to this role, he served as the Site Head of Quality for the Holly Springs Seqirus plant. Before joining Seqirus, he worked at Biogen as the Director of Global Stability and also as a Global Regulatory CMC lead. Before joining Biogen, 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 operational excellence. He is a member of the CASSS Board of Directors and was a member the United States Pharmacopeia (USP) 2010-2015 Monograph 2 Expert Committee and 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.

Validation Week 2021


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