Vikram Roongta

As a leader in the analytical chemistry department, was responsible for managing direct reports, ensuring effective collaboration between departments and clients, implementing strategic initiatives, allocating project resources and managing annual budgets. Delivered timely key data for FARXIGA (SGLT2 diabetes drug; structure ID of the parent compound in discovery, key metabolites and absolute bioavailability in humans) through all phases of drug discovery and development, including a complete bio-analytical package, to successfully achieve approval by the FDA and other regulatory agencies. Extensive experience in the integrated application of analytical tools to solve issues during drug discovery and development, such as structure confirmation of unknowns, metabolites, impurities, quantitation, profiling and biomarkers. Established metabonomics for metabolic profiling of small molecule and biomarker identification at Bristol Myers Squibb. Managed multiple bioanalytical projects under GLP and FDA guidance, prepared bio-analytical packages for regulatory filings and scientific liaison between clinical teams and contract research organizations. Experience in validated method development, GXP compliance, knowledge of ICH, FDA guidelines for stability, CMC requirements, NDA, sNDA and clinical bioequivalence studies. Responsible for majority of bio-analysis for phase I, II and III clinical studies (drug-drug interactions, bio-equivalence, absolute bioavailability, etc) for FORXIGA which was successfully approved by FDA in 2013. Specialties: Analytical, Organic, Physical, Biochemistry, Biology, and Pharmacology.Expertise in NMR, LC, LC-MS/MS and other analytical techniques. Regulated bio-analysis using LC-MS/MS.GXP compliance and knowledge of ICH and FDA guidelines.