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.

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.

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.

Weston, FL

Weston, FL

Hauppauge, NY

Master Of Science (Ms), Analytical Chemistry

Bachelor'S Degree, Pharmacy