Jayminkumar Patel

Experience

• 

  Amneal Pharmaceuticals

  Jun 2011 - Apr 2015

  Scientist II

  • Work in a cross-functional team to perform QC analysis for various samples of Finished Products, Stability and In-process material.• Have depth knowledge of USP methodologies, ICH Guidelines, cGMP testing and FDA regulation.• Have ability to perform HPLC analysis, Dissolution unit.• Prepared analytical process flow chart and executed the work in timely manner as needed.• Routinely perform sample analysis of Finished Product and Stability testing for Assay, dissolution (Apparatus I and II), content uniformity (HPLC), KF water determination, IR testing, UV-Visible spectroscopy and disintegration.• Conduct analytical testing of In-process material for blend content uniformity, particle size by sieve analysis, bulk density and tap density. • Execute testing on cleaning validation samples by HPLC.• Routinely prepare sample solutions, stalk & working standard solutions, placebo solutions, diluents and mobile phase for HPLC analysis.• Prepare dissolution media, buffer solutions and setting up dissolution bath for tablet dissolution testing. Periodically perform calibration of Dissolution apparatus I and II• Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings• Analyze analytical data, identify trends and provide recommendation.• Train and provide technical guidance to junior scientists.• Conduct laboratory investigation and prepare laboratory investigation report.• Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.• Evaluate and improve existing test methods Show less

• 

  Novel Laboratories, Inc.

  May 2015 - Oct 2015

  Scientist II

  • Working on Suspension, Topical solution testing for Assay, and Related Compound.• Performing testing on Ointment like Assay, Impurity, Viscosity, Minimum fill, PH, Density.• Routinely Perform calibration and verification of Karl fisher instrument with water.• Preforming Dissolution of Gel and Delayed Release dosage form.

• 

  Kashiv BioSciences LLC

  Nov 2015 - Mar 2020

  Sr. Scientist I

  • Performing sample analysis of Finished Product and Stability testing for Assay, Dissolution, Related compounds, Residual Solvents.• Performed Raw material Testing like Assay, LOD, IR, Heavy metals.• Performing Test like Particle size using Malvern 3000, Residual solvents by GC.• Working On Excipient Release.• Developed method for cleaning verification.• Develop and validation analytical method for drug substances, drug products, and excipients• Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.• Write protocols, reports, methods, standard operation procedure, change control, and submission documents.• Provide analytical support for formulation and process development.• Perform independent scheduling and coordination of activities. Show less

• 

  Amneal Pharmaceuticals

  Apr 2020 - now

  • Leading a group of people for commercial testing, exhibit batches, raw material testing.• Coordinate with project manager regarding future testing and release timeline.• Performing sample analysis of Finished Product and Stability testing for Assay, Dissolution, Related compounds, Residual Solvents.• Performed Raw material Testing like Assay, LOD, IR, Heavy metals.• Performing Test like Particle size using Malvern 3000, Residual solvents by GC.• Working On Excipient Release.• Developed method for cleaning verification.• Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.• Investigating OOS, OOT and OOAL and writing all reports• Provide analytical support for formulation and process development.• Perform independent scheduling and coordination of activities. Show less

  • Manager

    Mar 2023 - now

  • Quality Control Supervisor

    Apr 2020 - Sept 2023