Career Goal: Innovation Led Research & Development in the Health Care Industry Professional Experience:A Research Scientist (with M.Tech & PhD in Biotechnology from IIT, Kharagpur) with 10 years experience in Biotechnology research, research on drug development and advanced cancer biology. Extensive research experience in the filed of advanced cancer biology such as protein-protein interactions and their signaling in cancer.Expertise in development, qualification and validation of in vitro methods for the biosimilar product development with the following applications: A. Product Release; B. Stability Studies; C. Product Biosimilarity/ Comparability; D. Impurity Characterization; E. Immunogenecity Assessment. The various in vitro methods that are developed and validated includes cell proliferation assays, reporter gene assays, receptor ligand binding assay, ELISA based methods. Also an expert in developing and validating in vivo bioassays, PK/PD studies for biotherapeutics development in various animal models. Worked on a very diverse set of biosimilar molecules such as cytokines, hormones, Interferons as well as monoclonal antibodies for potency determination, product characterization and Immunogenecity assessment.A member of the USP-IPC joint working Group on Bioassays and is highly conversant with the major regulatory framework (such as DCGI, EMEA as well as US-FDA) of the world as it applies to safety and potency of biosimilar product development and marketing.Subject Matter Expert (SME) on Bioassays for the CMC of Biotherapeutics Development at Intas Biopharmaceuticals Limited.Specialties: Multidisciplinary knowledge of and skills in areas such as: Preclinical Drug DevelopmentMolecular BiologyCell Biology & Cell CultureIn Vitro / In Vivo Potency assays; High Throughput ScreeningClinical Immunogenecity assessment throughout drug product cycleEMEA/FDA regulations for Preclinical & Analytical studiesDevelopment & Validation of In Vitro methods