Manish Patel

Experience

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  PAR Laboratories Inc

  Sept 2012 - Mar 2014

  Officer - Quality control (OSD)

  - Coordinated and performed analytical tests to comply with established standards and specifications. - Calibrated and maintained laboratory equipments. - Performed technical laboratory functions in compliance with guidelines and safety requirement

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  Claris Limited

  Mar 2014 - Jun 2015

  Sr. officer - Stability studies (Injectables)

  - Prepared schedules for the respective products analysis and maintained the records for the same. - Carried out analysis of products as per defined procedures.- Preparation of stability study calculation sheets and summery sheets.- Preparation of trend analysis for stability results

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  Piramal Pharma Solutions

  Jul 2015 - Dec 2015

  Sr. Research Associate - Analytical development laboratory

  - Generated assay data and communicated results and reports to multidisciplinary project teams to influence progression in discovery and development. - Developed methodologies on HPLC for analysis of compound synthesized by R&D scientists to test for purity. - Calibrated and maintained laboratory equipments.- Created spreadsheets and other forms of documentation to accurately record and calculate analytical results

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  Troikaa Pharmaceuticals Ltd.

  Dec 2015 - Feb 2022

  Sr. Executive - R&D Analytical

  - Developed methodologies for assay, related substances, dissolution and content uniformity in pharmaceutical products such as solid orals, Injectables and topical dosage forms.- Performed analysis using sophisticated lab instruments like HPLC, UPLC, GC, LC-MS, UV spectrophotometer, Auto titrator, KF, FTIR, brooke field Viscometer, Rheometer etc.- Performed comparative dissolution study, dilution study, drug -excipient compatibility study, solubility studies etc. - Created spreadsheets and other forms of documentation to accurately record and calculate analytical results. - Partial analytical method validation, method verification and method transfer activities. - Prepared standard testing procedures, SOPs, protocols and reports for method development, method verification, method transfer. - Performed analysis of stability products and prepared reports and co ordinate with other department for smooth functioning. - Performed in-vitro drug release study using franz-diffusion apparatus for topical products. Show less

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  Amneal Pharmaceuticals

  Feb 2022 - now

  Analytical scientist - Analytical research and development

  - Responsible for Analytical method development and method validation for tests like Assay, Related substances, Unit dose homogeneity, CU , Dissolution of ophthalmic formulations for US market using HPLC, UPLC, USP Type-I, II, IV apparatus.- Performed analysis using sophisticated lab instruments like HPLC, UPLC, GC, LC-MS, Ion chromatography, Malvern master sizer 3000, UV spectrophotometer, Auto titrator, KF, Tensiometer, FTIR, density meter, brooke field Viscometer, Rheometer.- Involved in Impurity isolation and characterization.- Performed method transfer activities, Stability studies and trend analysis.- Document all experimental data in accordance with ALCOA and ALCOA+ and Preparation of AMDR, AMVR, MOA, SOP, Investigation report.- Review of analytical data and release of COA for in process and finished products.- Responsible for investigation, OOS, OOT and lab incidents with preparation and review of hypothesis studies protocol and investigation.- Troubleshooting related to analytical methods, instruments.- Experience of USFDA regulatory audits. Show less