Vidit Shah

Manager Ii, Analytical Sciences @Tarsus Pharmaceuticals, Inc.

Irvine, CA, US

Supervise and coordinate the development and qualification/validation/transfer of analytical methods at CMOs to meet project timelines- Develop timelines, identify critical analytical issues, lead problem solving of technical issues, investigate and resolve OOT/OOS results- Develop/optimize/troubleshoot analytical methods at CMOs- Apply expertise in HPLC/UPLC/GC as well as knowledge of other relevant pharmaceutical analytical techniques-Review analytical methods, validation protocols and reports- Review release testing and stability testing results for drug products- Tabulate and summarize stability results for regulatory submissions- Support regulatory filings including INDs, IMPDs, NDAs, supplements, briefing packages, and other documents of filings- Understand cross-functional needs with analytical, regulatory, clinical, quality assurance, and production concerning the entire drug development process- Prepare and present plans on analytical method development strategy and results to colleagues and management- Write, read technical papers, reports, reviews- Maintain current understanding of relevant scientific and technical developments.

Rajiv Gandhi University of Health Sciences

Bachelor's degree

Governors State University

Master of Science (MS)