James Mencel, Ph.D.
Senior Drug Substance Consultant
A Yale educated chemist, Dr. Mencel has served the pharmaceutical industry for over 30 years with practical experience in all aspects of synthetic chemistry and API development as well as early drug product formulation. In this capacity, Jim is technically proficient in several languages which serves his work with the global CMO community.
As a DSI subject matter expert, Jim assists our clients in providing timely technical assistance as both an author and advisor. Jim began his career in Discovery Chemistry and progressed to peptide and small molecule API chemical process R&D at Rhone Poulenc Rorer, and then Johnson Matthey with a focus on lab-to-plant transfer for cGMP clinical supply and commercial manufacturing and on inter-site technology transfer. Jim oversaw process & analytical development for API process scale-up; oversaw formulations R&D; and was responsible for GMP API & drug product manufacturing.
Jim joined DSI in 2015 from Galleon as an expert process chemist whose career focus has evolved toward applying principles of quality risk assessment and sound science to provide CMC guidance to all aspects of his area of drug substance.
- Oversees API synthesis design and process transfer and API/Formulation sourcing support
- Assists clients in providing timely technical assistance as both an author and strategic advisor
Jim influences and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. In this capacity, he has proven indispensable.
- Tech Transfer
- API/ Drug Substance
- Patent & Due Diligence
- Small Molecule
- Peptides & Peptidomimetic
- Risk Assessment
- API Synthesis Design
- Process Chemistry
- CMO Selection