Jim Mencel, PhD
Director of Chemistry Development
Jim Mencel, PhD, is a Senior Drug Substance Consultant with DS Inpharmatics (DSI), a consulting firm with expertise in regulatory affairs, chemistry, manufacturing and controls (CMC) and quality assurance. He has 35 years of experience in the pharmaceutical industry, supporting API characterization and synthesis at the interface between Discovery Chemistry and candidate nomination and continuing with chemical process development through Phase I to commercial launch. His technical reach encompasses small-molecule and peptide process chemistry, drug product and analytical development, and GMP manufacturing for small-molecule and peptide APIs. He has managed full CMC development programs for clinical proof of concept as well as process implementation for API manufacturing, and has provided technical, regulatory, and IP support to legacy commercial manufacturing. His experience includes program management in innovator/biotech organizations, CROs, CMOs and generic drug development.
Dr. Mencel has also guided parenteral formulations development and GMP manufacturing, with a focus on sterile parenteral products and nanoemulsions, and has been responsible for the development and validation of analytical methods associated with raw material release, in-process controls, product release, stability and cleaning.
His focus is to apply principles of quality risk assessment and sound science to guide the development of robust processes and the preparation of technical packages for regulatory filings. He serves as the subject matter expert for regulatory and patent filings, for follow-up response to regulatory and patent authorities and has authored regulatory filings.
He received both his master's and PhD in organic chemistry from Yale University and his bachelor’s degree in chemistry from Fairfield University.