Edward J. Smith, Ph.D. is Principal Consultant, Packaging Science Resources, a consulting group that provides technical services in packaging and training to the pharmaceutical industry. He recently retired from Wyeth Pharmaceuticals, where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products. Prior to that, Dr. Smith was also associated with Helvoet Pharma Inc. as VP of Technical Affairs and West Pharmaceutical Services in various technical capacities such as VP of Scientific Affairs & Technical Training, VP of Technical Service & Regulatory Affairs, and VP of Research. Before beginning his industrial career, he was a member of the Department of Chemistry at St. Joseph’s University (Phila., PA). He holds a B.S. in Chemistry from Villanova University and received his M.S. & Ph.D. in Analytical Chemistry from Seton Hall University (So. Orange, NJ).
He is a member of the PDA, the ACS, and loPP. Within PDA, he leads the Packaging Science Interest Group, and is on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG). He is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products. He is a member of the faculty of the PDA Training and Research Institute and is a member and Secretary of the Board of the PDA Foundation. As a member of ISO/TC 76 he represents the U.S.A. at ISO forums on pharmaceutical packaging. He is a member of the ACS Consultants Network. He has published many articles and chapters on pharmaceutical packaging and is a frequent speaker at industry meetings and courses related to extractables/leachables and cold chain.