Heta Desai

Working in Pharmaceutical industry for 5 Years and based in New Jersey.

Actively looking for job opportunities in Bay Area

Scientist III (Extractable and Leachable Team), 02/2022 to Current

Amneal Pharmaceuticals - Piscataway, NJ

• Lead and managed multiple projects for Extractable and Leachable - from development to data analysis of complex dosage forms (small and large molecules) to support regulatory filings. Independently managed timelines and met all ANDA filling deadlines to meet organizational objectives.
• Resolving and drafting responses to FDA deficiencies.
• Communicated and managed outside testing with External contract vendors. Simultaneously managed and supported several international complex projects, meeting all pertinent milestones.
• Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.

Scientist II (Extractable and Leachable Team), 01/2020 to 02/2022

Amneal Pharmaceuticals - Piscataway, NJ

• Analytical Method development and Experiment design for Extractable and Leachable study analysis solid dosage form, parental and injectable finished products, stability stations, in-use studies for ANDA products using instruments such as GC-MS, GC-FID, LC-MS, ICP-OES, ICP-MS, HPLC, UPLC. Developed Characterization testing for Drug development
• Worked on Method development for Inhalations and Nasal products Method Development
• Analyzed and troubleshooted challenges with instruments during analytical method development and CMC testing.
• Designed In-house Methods and Protocols for Validation and Release testing. Worked on FDA deficiencies for filed ANDA products with report designing.

Master of Science, Analytics, 06/2022

Harrisburg University of Science and Technology - Harrisburg, PA

Master of Science, Biomedical Engineering, 05/2017

The University of Texas At Arlington - Arlington, TX

Bachelor of Science, Biomedical Engineering, 05/2015

Gujarat Technological University - Gujarat, India