John Maddalena, Ph.D.

Vice President, Scientific Strategy, Prolytix

John Maddalena, Ph.D., joined Prolytix in 1992. He was responsible for the development and implementation of a quality management system (QMS) and subsequent ISO 9001 registration to support Prolytix’s manufacturing activities. More recently, John assumed oversight responsibilities for Prolytix’s GMP operations which focuses on providing GMP analytical testing services to support the development and release of protein therapeutics. He specializes in the development and validation of analytical test methods. John received his B.S. in microbiology from the University of Notre Dame and his Ph.D. in cellular and molecular biology from the University of Vermont. He also holds an M.Ed. from the University of Massachusetts. For more information, visit

Talk to John about these topics and more:  

  • Analytical chemistry, manufacturing, and controls (CMC) 
  • The development of next generation biotherapeutics 
  • Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) 
  • Corrective and preventive action (CAPA) 
  • Analytical and bioanalytical method validation 

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