Overview

Gender

female

Patricia Johnson is our Executive Director, Regulatory CMC, bringing with her over 19 years of experience in the pharmaceutical industry.

Patricia was previously the Director of Regulatory CMC at Pharmasset, Inc. from April 2006 to September 2007, where she was responsible for global CMC regulatory activities for nucleotide products in various phases of clinical development. Her responsibilities included direct communication with the FDA regarding both CMC and clinical issues.

Patricia’s vast manufacturing and analytical knowledge provided the development strategy necessary to support clinical and marketing applications.

Prior to her service at Pharmasset, Patricia was employed by Merck & Co. Inc. where she had over 10 years of experience in global regulatory CMC. Her experience ranged from original IND and NDA submissions to global post approval change activities through deletions of commercial product.

Patricia directed several high level cross-functional teams to transfer product technology from research to manufacturing and also provided development process guidance for early clinical development teams.

Prior to her regulatory endeavors, she managed the Reference Standard and Drug Substance Stability Testing programs and also developed and validated analytical methods for release testing of drug substances.

Patricia received a B.S. in Chemistry from Seton Hall University and a M.S. in Analytical Chemistry from the University of Massachusetts, Amherst.