Hitendra (Vijay) Jethwa, PhD, MBA

Hitendra (Vijay) Jethwa, PhD, MBA

Senior Consultant

Vijay Jethwa, PhD joined Biologics Consulting as a Senior Consultant (Analytical/CMC) in August 2013. Vijay comes to Biologics Consulting with over 20 years of industry experience in the development, validation, and routine performance of bioassays and immunoassays for diagnostics, PK/PD studies, drug substance & drug product lot release and stability, as well as immunogenicity assessments.

Most recently, he started up the new GMP Bioanalytical Laboratories at the Merck Vaccines Facility in Durham, NC. His group developed and transferred analytical methods for the characterization and release of live virus vaccines. Prior to joining Merck, Vijay was at Biogen Idec for over 12 years in various capacities. Most recently, he was the Director of Technical Development at Biogen Idec and was responsible for several early and late stage Biosimilars programs. Vijay was responsible for Biosimilars strategy, direction, and objectives for all CMC activities from R-to-D transition through Preclinical and Clinical stages, including overseeing cell line development, up- and down-stream process development, formulation and final container closure development, analytical testing and specifications, regulatory filings, and clinical manufacturing and Quality release.

Vijay prepared and presented Quality sections for Regulatory advice meetings from EMA, MHRA, Paul Erlich Institute/BfArM, and FDA. He served as the Site-head of the cGMP Bioassay, Microbiology, and Virology QC Laboratories at the Biogen Idec Large Scale Manufacturing Facility in Research Triangle Park, NC for over 6 years. Vijay established strategy, direction and objectives for a group of over 50 scientists responsible for DS/DP release and stability testing, in-process testing, environmental monitoring and water testing, raw materials testing, testing for adventitious agents, and CMC support. Vijay has authored, reviewed, and approved sections of several regulatory submissions and responses to various agencies. Vijay has presented on bioanalytical topics at several national and international scientific symposia.

Vijay established new Preclinical and Clinical GLP testing laboratories at Biogen’s facilities in North Carolina, including laboratory design, equipment sourcing and validation, supporting antibody and PK/PD testing for various GLP/GCP studies. He supervised assay development, validation, and transfer activities for immunoassays and bioassays.

Vijay holds a BS degree in Biology, a BS degree in Medical Technology, an MBA, with concentration in Leadership & Strategy, and a PhD in Molecular and Cellular Pathology, all from the University of North Carolina at Chapel Hill.

As a Senior Consultant with Biologics Consulting, Vijay will utilize his broad technical expertise to assist clients in the following areas:

Development and Validation of Bioassays and Immunoassays for:

  • In-process testing
  • Lot release
  • Stability
  • Structure-Activity Relationship
  • PK/PD
  • Immunogenicity

Education

MBA, Kenan-Flagler Business School, University of North Carolina, Chapel Hill, NC (2012)

PhD, Molecular and Cellular Pathology, University of North Carolina, Chapel Hill, NC (1998)

BS, Medical Technology, University of North Carolina, Chapel Hill, NC (1992)

BS, Biology, University of North Carolina, Chapel Hill, NC (1987)