SANTOSH JADHAV, Deputy General Manager - Quality Control, Bharat Serums and Vaccines

Santosh Jadhav serves as DGM, Biotech Quality Control at BSV, where he is the principal authority on allmatters related to handling of QMS, Audits and commercial testing and 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 degrees in biotechnology from the University of Nanded (SRTMU) and his bachelor’s degree in Microbiology from DSM college, Parbhani. He spent 18 years in 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 andmanagement experience from 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 Key team member for development of first Indian filgrastim Biosimilar product (Intas Grastofil®) approved by European Regulatory agency. He also, significantly contributed towards development of etanercept biosimilar (Nepexto®-Lupin) and filgrastim Biosimilar (Lupifil®) which was later approved by EMEA and PMDA respectively.The main areas of hisinterestare 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 lettersto 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.