Utah State University

Expertise:  Analytical development and validation, Resolving analytical issues in R&D, manufacturing, QC, and stability (OOS and OOT). Impurity isolation and identification. CMC sections for FDA and EMA submission. Reference standards’ strategies. Strategic engagement with CROs, Continuous improvement (LEAN and Green Belt), and Technical project management.

Experience:    Led research teams at Baxter. Managed international CRO relationships with over 200 FTEs. Organized workshops at American Association of Pharmaceutical Scientists (AAPS)

Other:  Member of American Chemical Society and AAPS. Taught graduate level course on Advanced Topic in Analytical Chemistry – Chromatography at UW-Milwaukee.

Email Shreekant Karmarkar CV