Speaker Profile
Santosh Jadhav

Santosh Jadhav MSc

Mumbai, Maharashtra, India

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Santosh Jadhav serves as DGM, Biotech Quality Control at BSV, where he is the principal authority on all matters related to the handling of QMS, Audits, commercial testing, and the release of biological products to the market. In his current role, he provides regulatory guidance, manages, and leads teams in strategic decision-making, ensuring quality submissions to the Food and Drug Administration.

Santosh Jadhav earned his master’s degree in biotechnology from the University of Nanded (SRTMU) and his bachelor’s degree in Microbiology from DSM college, Parbhani. He spent 18 years in the pharmaceutical industry at Wockhardt, Panacea Biotec, Intas, Lupin, and Stelis Biopharma. An accomplished analytical researcher and QC operations leader with expertise in the areas of analytical method development and validations, strategic planning & execution, Regulatory Compliance, policy development & risk mitigation, quality data collection & analysis, and drug product research & development.

He has a broad spectrum of scientific and management experience from the industry. Prior to joining BSV, he worked at Stelis Biopharmaceutical (CDMO) as Quality control Head and contributed to file 4 ANDA to the US FDA and 1 MAA application to EMEA. He served as a Key team member for the development of the first Indian filgrastim Biosimilar product (Intas Grastofil) approved by the European Regulatory agency. He also significantly contributed towards the development of etanercept biosimilar (Nepexto-Lupin) and filgrastim Biosimilar (Lupifil) which were later approved by EMEA and PMDA respectively. The main areas of his interest are Chromatographic (HPLC, UPLC) and Capillary Electrophoresis (CE) based method development and validations for Biologics, especially for the monoclonal Antibodies, Statistical Data analysis (DoE, R&R gauge, ANOVA, Control Charts, etc.), Technology transfer, Quality Management System (Change control, Deviation, CAPA, OOS, OOT, etc.), Process validation, Aseptic processing practices, cleaning validation in line with PDA TR29 and TR49, Device testing as per ISO 11608 and USP <380>, Interpretation of FDA warning letters to find gaps in the quality systems.

Through his 18-year professional career, he has established his leadership in industrial R&D, quantitative methods and modeling, and model-based strategic decision makings in regulatory and industrial settings for generic and new drugs.
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