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Santosh Yadav, Ph.D.
Principal Scientist at Merck Manufacturing Division


Santosh is Principal Scientist at Merck Manufacturing Division in Analytical Program Leadership team. Santosh lead IO late stage programs with 10 years of experience in multiple Pharmaceutical industries in in-line and pipeline biologics to provide end to end visibility from method development, qualification, validation, technical transfer, life cycle management, specification, critical quality attributes, stability studies, reference standard strategy, process and analytical comparability, testing strategy for in-process intermediates, controls, raw materials, and biological critical reagents.

Santosh also author IND, BLA, NDA, and provide responses to regulatory agencies questions, and actively participate/present in CASSS, BPOG and WCBP.

Santosh has completed her Doctorate degree from University of Cincinnati, OH in Chemical Engineering with specialization in Pharmaceutical Sciences. She worked in Ashland Chemicals after Ph.D. and worked in Johnson and Johnson before joining Merck Research Laboratory to work on Keytruda and later joined Merck Manufacturing Division as Keytruda moved in commercialization space.

Agenda Sessions

  • Smart Strategies to Accelerate Analytical Timelines to Support Biologics Development and Commercialization

  • Panel: Early vs. Late Stage - How to Accelerate Analytical Timelines for Biologics