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 2013. Vijay comes to Biologics Consulting with over 25 years of industry experience in the development, validation, and routine performance of potency assays, cell-based bioassays, and immunoassays for diagnostics, PK/PD studies, drug substance & drug product characterization, 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 including leading all CMC activities related to biosimilar development and serving as the site-head of the cGMP Bioassay, Microbiology, and Virology QC Laboratories. He established GLP testing laboratories at Biogen, including laboratory design, equipment sourcing and validation, supporting antibody and PK/PD testing for various GLP/GCP studies.

Vijay prepared and presented Quality sections for Regulatory advice meetings and has authored, reviewed, and approved sections of several regulatory submissions (IND, IMPD, BLA, etc.) Vijay has presented on bioanalytical topics at several national and international scientific symposia.

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 potency and immunogenicity
  • CMC Analytical support
  • QA/QC support
  • GLP and GMP auditing, including focused data integrity audits
  • Regulatory submission gap analyses, writing and review (IND, IMPD, BLA, etc.)

Areas of Expertise

  • 25+ years of experience in the development, validation, and routine performance of bioassays and immunoassays for potency, host cell protein assays, host cell DNA assays, PCR-based mycoplasma testing, rapid microbiology assays, and immunogenicity assessments.
  • Biologics pre-IND through post-marketing CMC Analytical support including strategy and execution (Technical and Regulatory)
  • Laboratory Quality Systems development and implementation
  • Global GLP/GMP auditing, including PAI-preparedness and Data Integrity Auditing
  • Development of Biosimilars
  • PhD Molecular & Cellular Pathology; MBA Leadership & Strategy

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)