Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Hetakumari Desai

Piscataway,NJ

Summary

Dynamically skilled Scientist with extensive research and development experience. Holds a broad set of analytical and technical skills with over 5 years of experience in pharmaceutical industry. Well-versed in developing experiment protocols and analyzing the results while applying innovative research methods to improvise and drive industry progress.

Overview

5
5
years of professional experience
1
1
Certificate

Work History

Scientist III

Amneal Pharmaceuticals
Piscataway, NJ
02.2022 - Current
  • Lead multiple projects for Extractable and Leachable end to end developmeont of complex dosage forms (small and large molecules) to meet organizational objectives.
  • Simultaneously managed several complex projects, meeting all pertinent milestones.
  • Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.

Scientist II

Amneal Pharmaceuticals
Piscataway, NJ
01.2020 - 02.2022
  • Analytical Method development for Extractable and Leachable study analysis for developed finished products stability stations for ANDA products using instruments like GC-MS , GC-FID, LC-MS, ICP-OES , ICP-MS , HPLC , UPLC.
  • Analyzed and troubleshooted challenges with instruments and analytical method development.
  • Worked for FDA deficiencies for filed ANDA products with report designing.
  • Worked with Inhalations and Nasal products development

Scientist I

Amneal Pharmaceuticals
Piscataway, NJ
01.2018 - 01.2020
  • Performed routine analysis on Raw Materials , In-process, Finished products using instrument techniques like HPLC , UV-IR spectrophotometry, KF, Potentiometer, Malvern Sizer 2000 & 3000, etc as per USP monograph / In house and other compendial monographs.
  • Performed real time documentation of experimentation following cGMP guidelines.
  • Prepared/Reviewed test procedures, SOP's and testing protocols for Method Validation.
  • Performed Method Validation and Method Transfers with cross functional teams

Education

Master of Science - Analytics

Harrisburg University of Science And Technology
Harrisburg, PA
06.2022

Master of Science - Biomedical Engineering

The University of Texas At Arlington
Arlington, TX
05.2017

Bachelor of Science - Biomedical Engineering

Gujarat Technological University
Gujarat, India
05.2015

Skills

Instrumentation and Laboratory skills

  • GC-MS / GC-FID (Agilent)
  • ICP-MS and ICP-OES for Trace Elemental Analysis(Thermo Fisher)
  • LC-MS (Agilent)
  • HPLC, UPLC (Waters)
  • Malvern-Particle size analyzer 2000 & 3000 , Microscopy, CHNS Analyzer
  • FTIR Spectrophotometry, Anton Par Densimeter, UV Spectrometer, KF Titrator, Metrohm Potentiometer
  • Dissolution and Drug release method development ( USP IV Apparatus - Sotax, Distek )

R&D Activities

  • Reverse Engineering, Product Characterization, Raw material testing, Extractable and Leachable Method development and Validation , FDA/GLP compliance testing
  • Proficient in Microsoft Office for Protocol drafting, Results , ANDA submission reports to FDA
  • Able to lead multiple projects, efficient at time, task and resource management, maintaining timelines

Certification

  • cGMP and cGLP , Amneal Pharmaceuticals - [Timeframe]

Timeline

Scientist III

Amneal Pharmaceuticals
02.2022 - Current

Scientist II

Amneal Pharmaceuticals
01.2020 - 02.2022

Scientist I

Amneal Pharmaceuticals
01.2018 - 01.2020

Master of Science - Analytics

Harrisburg University of Science And Technology

Master of Science - Biomedical Engineering

The University of Texas At Arlington

Bachelor of Science - Biomedical Engineering

Gujarat Technological University

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Hetakumari Desai