Vijay Jethwa

About Vijay Jethwa

A seasoned strategic leader with a proven track record in global biopharmaceutical development, spanning from cell line generation to regulatory filings and commercialization. Expertise includes:Comprehensive Leadership: Skilled in guiding CMC and cross-functional teams in matrix environments, ensuring effective program execution.Operational Management: Successfully managed a department of 50+ professionals in a cGMP setting, demonstrating excellence in leadership and team development.Technical Proficiency: Deep understanding of healthcare, biotech, and pharmaceutical industries, with extensive knowledge of the interdependencies among research, technical development, preclinical, clinical, and regulatory processes.Strategic Problem Solver: Demonstrated ability to conduct strategic analyses, resolve complex issues, and deliver results through strong organizational and project management skills.Influential Communicator: Exceptional capabilities in communication, negotiation, decision-making, and problem-solving, with a talent for influencing outcomes without direct authority.Specialized Expertise: Potency assays, bioassays, immunogenicity assays, CMC development, biosimilars, cell and gene therapy, therapeutic vaccines, immuno-oncology, GMP/cGLP, quality control, quality assurance, regulatory affairs, assay development and validation, data integrity, and Six Sigma Black Belt certification.

Experience

1. Principal Consultant

   Biologics Consulting

   Jul 2013 — Present · US

   Assist clients with CMC and Regulatory Affairs, specializing in the following areas: CMC Analytical; Bioassays, Immunoassays, Microbiology and Molecular Assays; Biosimilars; Cell and Gene Therapy, Vaccines, Immuno-oncology, CMC Strategy and Execution; Laboratory Quality Systems; LEAN Laboratory design and start-up; GMP/GLP and Data Integrity auditing

Education

• University of North Carolina at Chapel Hill

  MBA, Leadership & Strategy

  2010 — 2012

• The University of North Carolina at Chapel Hill

  PhD, Cellular and Molecular Pathology

  1995 — 1998

• The University of North Carolina at Chapel Hill

  BS, Biology

  1983 — 1987

• The University of North Carolina at Chapel Hill

  BS, Medical Technology

  1990 — 1992

Skills

• Monoclonal Antibodies
• Immunology
• Assay Development
• Glp
• Pharmaceuticals
• Ind
• Hplc
• Sds-Page
• Technology Transfer
• Biochemistry
• Protein Chemistry
• Biotechnology
• Protein Purification
• Microbiology
• Regulatory Submissions
• Pharmaceutical Industry
• Sop
• Fda
• Process Validation
• R&D
• Cell Culture
• Validation
• Cross-Functional Team Leadership
• Drug Discovery
• Cell Based Assays
• Life Sciences
• Antibodies
• Quality Assurance
• Qc
• Lims
• Process Development
• Medical Devices
• Clinical Research
• Molecular Biology
• Drug Development
• Gcp
• Biopharmaceuticals
• Clinical Trials
• Elisa
• Regulatory Affairs