Edward J. Smith, Ph.D.

Ed SmithPrincipal
Packaging Science Resources LLC

Ed Smith is Principal at Packaging Science Resources LLC which provides consulting and training in the packaging of injectable drug products for the pharmaceutical, biotechnology, and medical device industries.

He leads the PDA Packaging Science Interest Group, and he also served on the Steering Committee of PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Reports 39 & 46 on cold chain best practices. Ed is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products (Extractables/Leachables). 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.

Prior to forming Packaging Science Resources, Ed worked for Wyeth Pharmaceuticals where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products and he also served as a technical expert on parenteral packaging issues particularly with respect to the management of extractables and leachables. Prior to Wyeth he worked for Helvoet Pharma Inc. and West Pharmaceutical Services in various technical management positions.

He holds a B.S. in Chemistry from Villanova University and received his M.S. and Ph.D. in Analytical Chemistry from Seton Hall University.