Shalini Sharma

Shalini Sharma has a diverse and extensive work experience in the pharmaceutical industry. Shalini started their career in 2003 at Intas Pharmaceuticals Ltd., where they served as a Principal Scientist. Shalini'sresponsibilities included method development, qualification, and product characterization for various Biosimilar projects. Shalini also led the Analytical Similarity programs for global filings, particularly for projects like EPO, Filgrastim, and Pegfilgrastim.

In 2015, Shalini joined USV PRIVATE LIMITED as an Assistant Principal Scientist and later became the Deputy General Manager. During this period, they played a crucial role in the lab management and development of a GMP/GLP compliant analytical laboratory. Shalini actively participated in the EMA approval process for Pegfilgrastim and the US-FDA approval of DMFs and ANDAs for two synthetic peptides.

Currently, Shalini is associated with Kashiv BioSciences LLC, where they hold the position of Associate Vice President. Shalini previously served as the Senior Director of Analytical Research Development and CMC Lead, responsible for the analytical development of the Biosimilar and generic peptides portfolio. Shalini'srole involved leading development, qualifications/validations, technology transfers, and engaging with regulatory agencies for development strategies, dossier submissions, and query responses.

Overall, Shalini Sharma has demonstrated expertise in analytical research and development, CMC leadership, and regulatory affairs in the pharmaceutical industry.

Shalini Sharma earned a Bachelor of Science (B.Sc.) degree in Chemistry from The Maharaja Sayajirao University of Baroda in 1998-2001. Shalini later obtained a Master's degree in Microbiology and Immunology from the same university in 2001-2003.