Vidit Shah Email & Phone Number

Irvine, California, United States

- 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.

San Diego, California, United States

San Diego, California, United States

• Independently conducts complex analysis with a thorough understanding of laboratory procedures.• Leads in drug product program as analytical development chemist to collaborate with other departments and support formulation development and manufacturing activities with pre-set timelines.• Develops and validates complex methods including stability indicating methods independently for early phase drug product development.• Evaluate and optimizes existing analytical methods to suit its purpose.• Investigates aberrant results, determination of root causes and recommends action plan.• Interacts with clients by providing updates and participating technical discussions through regular phone calls and emails.• Responds quickly to client requests and adjusts to priorities changes accordingly.• Works with advanced methods and designs and performs advanced experiments accurately, consistently and in a timely manner.• Writes/revises Standard Operating Procedures (SOPs), analytical methods, protocols and technical reports.• Assist and mentor junior level Scientist on analytical techniques training and troubleshooting issues.

Florida

• Participated in number of ANDA/IND submissions, some of them included First-to-file submissions.• Involved in pre-clinical development of active ingredients and its products.• Involved in Solid Dosage Form Products development to submission for approval by FDA• Received and responded to deficiency letters by FDA as and when required• Analytical Method Development, Stability Testing and support Regulatory Affairs.• Involved in writing Standard Test Methods, Standard Operating Procedures, Protocols and Reports.• Maintain, Troubleshoot and Calibrate various Analytical Instruments.• Analyzes active pharmaceutical ingredient and in process blend using non-chromatographic and/orwet chemistry methods.

Weston, Fl

Weston, Fl

Hauppauge, Ny

Master Of Science (Ms), Analytical Chemistry

Bachelor'S Degree, Pharmacy