Retired from Merck & Co. Inc. During his 35 year tenure he worked in the areas of process development/improvement; Quality; and Strategy for vaccines and biologics. During this time he served as VP of Vaccine Quality; VP Vaccine Technology and Engineering; and VP Biological Sciences and Strategy. He now leads a consulting company Barry Garfinkle & Associates, LLC. Barry has also served on the USP council of experts and Chaired the Committee on Vaccines & Virology. He has written several dozen papers on vaccine manufacture as well as chapters on validation and aseptic manufacturing.