John Hlavaty, Ph.D.

Senior Analytical Services Consultant

Dr. Hlavaty is an accomplished scientist with over 20 years of both large and small molecule drug product Analytical and QC experience. He is a skill bench chemist performing protein sequencing (Edman Degradation), amino acid and chromatographic analyses, peptide mapping, ELISA, gel and capillary electrophoresis, TOC, and Western Blot and corresponding validations for drug substance and drug product testing. Additional experience in QA, RA, and management of projects from R&D to commercial stages.

Led cross-functional team meetings by interacting with manufacturing, QA, supply chain, and RA teams. Authored SOP’s and CMC sections of IND, NDA, and BLA filings (includes FDA approved drugs), reviewed data, and interacted with FDA on CMC issues, including “Phase 4” projects (post- approval). Responsible for all OOS/OOT results and ensured laboratory accuracy. Directed teams per USP, ICH, FDA, DEA, EA, and TGA guidelines. Built and managed teams with as many as 13 direct reports, including Ph.D. level scientists.


Core Competencies

  • Analytical Strategy
  • Lyophilized Solutions
  • Liposomes
  • Antibodies/Proteins
  • Method Authoring
  • CMO Selection
  • Automation in Analytics
  • Validation Protocols
  • Small and Large Molecule