Bioniz - About Us



Sunil Shah, PH.D., RAC

Head of CMC

Dr. Sunil Shah is a pharmaceutical scientist with over 25 years of industry experience and currently serves as our Head of CMC. Sunil’s background provides expertise and in-depth understanding of product development, clinical & commercial supply manufacturing, analytical testing, and quality/regulatory plan integration. Sunil has authored several scientific publications and has filed multiple NDAs and INDs.

Prior to this role, Dr. Shah was a Senior Director of CMC at Spectrum Pharmaceuticals, Inc., where he was responsible for developing an oral pan HER inhibitor for NSCLC and multiple injectable product candidates for various oncology/hematology indications. Previously, Sunil held roles of increasing managerial and scientific leadership at several companies including Searle, Warner-Lambert/Pfizer, Amylin, Kemwell Pharma, Granules India Ltd.

Dr. Shah earned his Ph.D. in Pharmaceutics from The University of Iowa in 1988 and his bachelor’s in pharmacy from M. S. University, India. Further, Dr. Shah obtained a Regulatory Affairs Certification (RAC) in 2013.