Hardikkumar Ghelani

Experience

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  Apicore, LLC

  Jun 2010 - May 2014

  Chemist

  * Analytical Method Development & Validation of New formulated Products, Dissolution, %Assay, Related Substance, Content Uniformity, Hardness, Thickness. * In process Analysis, Intermediate Analysis, Raw Material Analysis, Finish Product Analysis, Cleaning Sample Analysis. * Analysis of formulated Products using HPLC, GC-MS, GC, UV-VIS, IC, pHmeter, FTIR, NMR, KF, Auto titration * Perform vendor qualification for new vendor * Lab cGMP Documentation, SOP Preparation, Certificate of Analysis * Manage all change controls and deviation reports; assist to prepare root cause analysis and preventive action. Show less

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  Aurobindo Pharma

  May 2014 - Nov 2014

  Chemist

  finished and stability products, using Various Instrumental techniques (HPLC, UPLC, GC, UV-VIS, IR ) as per USP monograph/In-house/ any other compendia monographs.• Independently plan and execute testing to meet established timeline.• Proficient in analytical method development and validations for test of assay, Impurity and dissolution of drug product and drug substances.• Handle deviations and Laboratory out of specifications with corrective and preventive action. • Responsible for Analytical method transfer from Analytical Development Lab / Different facility to QC lab.• Prepare and/or Review Test procedures, SOPs, and Protocols.• Developed methods at R&D level, Performed analysis on ACC & CRT stability samples & studied the trend sheet for any deviation Show less

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  Eurofins Lancaster Laboratories

  Nov 2014 - May 2017

  Senior Chemist

  • Perform Assay, Dissolution, Content Uniformity, Organic Impurity, Identification test on stability products, using Various Instrumental techniques (HPLC, UPLC, GC, UV-VIS, IR) as per USP monograph/In-house/ any other compendia monographs.• Perform Method validation for Assay, Impurity, Dissolution testing.• Responsible for Formal stability study (FSS) and Product Characterization study (PCS) of client’s Investigational New Drug (ING).• Perform trend review and approve periodic reports for accuracy, completeness and trending prior to submission to the FDA.• Review and approve Stability protocol and Stability report. • Manage all change control and deviation of the protocol, investigation and CAPA’s.• Maintain metrics for Stability testing completion. Maintains and updates stability summary charts for Client. Show less

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  GSK

  May 2017 - Jan 2018

  Associate Research Scientist
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  Genus Lifesciences Inc.

  Jan 2018 - Jun 2020

  Sr. Scientist
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  Merck

  Jun 2020 - now

  • Senior Scientist

    Nov 2024 - now

  • Scientist

    Jun 2020 - now