Vijay Dhawan Email & Phone Number | Core Expertise: Development of biologics through Chemistry Manufacturing & Control (CMC) leadership; Method Development and Assay Validation A highly driven Scientist with a demonstrated track record of success in rigorous characterization of complex biologics (using a wide array of techniques including SPR, ELISA, HPLC, IEF, CE, PCR and cell-based bioassays) in a GxP environment including design-of-experiment (DOE)-based assay development/validation following ICH guidelines for early (Ph I/II) to late stage (Pivotal/Ph III) programs and life-cycle management of method performance. Additional experience includes project management through Chemistry, Manufacture & Control (CMC) and/or Analytics leadership by leading activities across cross-functional teams; regular interactions with FDA, EMEA and CMO/CROs. Successful in building and nurturing teams.

Vijay Dhawan

Core Expertise: Development of biologics through Chemistry Manufacturing & Control (CMC) leadership;...
Westford, Massachusetts, United States

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Vijay Dhawan’s Location Westford, Massachusetts, United States

Vijay Dhawan’s Current Industry Sanofi

Vijay Dhawan’s Prior Industry Genzyme | Nitromed

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Head of Analytical Development/QC, Genomic Medicine

2021-08-01 00:00:00 - Present

Scientist II

2008-03-01 00:00:00 - 2014-02-01 00:00:00

Research Scientist II

2005-01-01 00:00:00 - 2006-01-01 00:00:00

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Vijay Dhawan is a Core Expertise: Development of biologics through Chemistry Manufacturing & Control (CMC) leadership; Method Development and Assay Validation A highly driven Scientist with a demonstrated track record of success in rigorous characterization of complex biologics (using a wide array of techniques including SPR, ELISA, HPLC, IEF, CE, PCR and cell-based bioassays) in a GxP environment including design-of-experiment (DOE)-based assay development/validation following ICH guidelines for early (Ph I/II) to late stage (Pivotal/Ph III) programs and life-cycle management of method performance. Additional experience includes project management through Chemistry, Manufacture & Control (CMC) and/or Analytics leadership by leading activities across cross-functional teams; regular interactions with FDA, EMEA and CMO/CROs. Successful in building and nurturing teams.