Dr. Ratnaswamy has over 25 years of experience in the development of parenteral formulations, drug products and analytical methods for a variety of biologics, antibodies, antibody-drug conjugates (ADCs), recombinant proteins and biosimilars. Gaya has extensive experience in protein formulation, fill/finish, lyophilization process development, technology transfers to CMOs, analytical comparability, analytical method development, qualifications, and transfers to CDMOs. She also has experience with developing CMC strategy and authoring regulatory documents. Gaya was previously Director of Analytical and Formulation Development at Agensys Inc, a subsidiary of Astellas Inc for 8 years. Prior to Agensys, she worked at Amgen Inc for 10 years in the Process and Product Development group. Since 2018, Gaya has been an independent CMC consultant. Gaya obtained a Ph.D in Chemistry from Brandeis University working on protein structure determination and completed post-doctoral fellowships at Princeton University and The Scripps Research Institute focusing on the biophysical characterization of proteins.