Ravi Rapolu

Background

About Ravi Rapolu

Ph.D. in Peptides from IICT, Hyderabad, and Postdoc from UW-Madison, USA, with 17 years of experience in Analytical R&D at reputable companies such as Dr. Reddy’s Laboratories, USP-India, Sai Life Sciences, Ind-Swift Labs, and Neuland Labs. Over the past 24 years, gained extensive real-time experience in large biomolecules/complex generics/peptides/proteins/oligonucleotides. My expertise covers sameness/high similarity studies, primary/secondary/tertiary/quaternary structural studies, aggregation/degradation, residual chiral, and peptide/protein content determination. I have proficiency in techniques such as LC-MS, CD, NMR-PCA, MD, FTIR, SEC-MALS, GC-MS, AUC, fluorescence/Thioflavin, UPLC, Prep-DAC, and others. In the small molecules/generics/API space, my experience includes regulatory filings (USFDA, EDQM, PMDA, TGA, KFDA), impurity profiling, addressing customer and plant queries, and CDMO for global customers. Worked extensively in formulation/excipients, focusing on GTI/nitrosamine developments, validations, and batch releases, as well as monograph modernization, discovery, and NCE molecules. Regulatory audits - USFDA, EDQM, and certifications such as ISO 9001, 14001, 45001, and 17025. Authored 15 research articles in peer-reviewed international journals on peptides, oligonucleotides, and impurities. Recognized with multiple awards, including the LIGHTNING Award, GOLD IMPACT Award, a letter of appreciation, and scholarships such as JRF, SRF, and PDF. I was also recognized as a Fast-track Scientist, ranking in the top 7% across the organization at Sai Life Sciences. With a proven track record in people management, I have successfully led teams of over 100 at Neuland and 70+ at Ind-Swift. I am also a certified Lean Six Sigma Master Black Belt with advanced project management and senior management training from IIM Calcutta.