Amruta Mhashilkar

Associate Director, Formulation & Process Development at Catalent

Speaker

Amruta Mhashilkar is currently an Associate Director of Formulation & Process Development at Catalent in St. Petersburg. She is a well-rounded and enthusiastic professional with a strong background in scientific and technical aspects of pharmaceutical development. Her expertise includes ANADA, ANDA, and NDA submissions, as well as the development and launch of prescription and VMS products. Amruta is proficient in CMC writing, oral drug delivery, and process development, with hands-on experience in pilot and scale-up cGMP manufacturing. She specializes in enteric and controlled release delivery systems and has a solid foundation in technology transfer and new product development. Her prior experience encompasses cell and tissue culture, protein purification, western blotting, PCR, transcriptomics, and gene editing techniques. In her current role, she manages over 40 pharmaceutical product development programs, guiding them from pre-IND studies through to commercial launches.