Mrunal Jaywant's Biography

Mrunal Jaywant, Senior Director, USP India Private Limited

Dr. Mrunal is a Senior Director R&D in the Chemical Medicines Department at USP India. She is responsible for Compendial Development Laboratory, Analytical Research and Development Laboratory and also, for the Development of Documentary Standards (Monographs) at USP India. Dr. Mrunal has over 20 years of Industrial experience that includes about 1 year association with USP India. Her experience includes several years in Pharmaceutical Industry where she has successfully led Analytical Research and Development Department at various capacities in Indian as well as Multi-National Organizations such as Perrigo, Watson, Unichem, Cipla. She has played a key role in Development, Validation and Transfer of Stability Indicating Analytical Methods for Drug Substance and Drug Products such as Assay, Related Substances by HPLC, Residual Solvents by GC etc. She has also been actively involved in Development of Analytical Methods for Estimation of Potential Genotoxic Impurities by LC-MS/ GC-MS etc.
She has vast experience in handling/ answering Regulatory Queries from US FDA and EDQM. She is well versed with the concept of QbD and has been instrumental in effectively implementing the same in R&D during Product/ Process/ Method Development. She has faced US FDA, MHRA and several customer audits during her Industrial tenure. She is having sound knowledge of FDA/ Regulatory requirements, ICH Guidelines and ISO 9001/ 17025 Standards.
Dr. Mrunal has several publications to her credit. She is also an approved referee for Ph. D. candidates.