Jasminkumar Patel Email & Phone Number

Mississauga, Ontario, Canada

Mississauga, Ontario, Canada

Mississauga, Ontario, Canada

•Performing Analytical Method Development, Method Validation and Method Transfer for Oral Suspensions, Oral Solutions, Creams and Ointments.•Engage in technical writing of Method Validation Protocol, Method Validation report, Forced Degradation Study Report and Test method for regulatory submission.•Executing stability testing in accordance with ICH/FDA guidelines.•Compiling stability testing reports for submitting to customer and or regulatory agencies (FDA).•Supporting analytical laboratory operation and assist product development, optimization, submission to appropriate regulatory agencies.•Assisting Formulation Development for Analytical Testing related to stability, compatibility and pre-validation studies.•Ensuring that all work is performed in compliance with the required applicable SOPs, cGMP, GLP, GDP and established Safe Work Practices (SWP).•Aiding the Product Development Team to ensure the timely completion of the projects.•Evaluation of prospective analytical method, literature, procedures and protocols to determine technical feasibility and project scope.

Vadodara Area, India

•Developed and validated analytical test methods for the testing of pharmaceutical products like Injectables, Suspension, Liposome and Lyophilized products per the ICH requirements. •Independently investigated literature and compendia sources to define an appropriate basis for analysis.•Provided project support for analytical activities in pre-formulation research or method validation and method transfer as needed.•Operated various laboratory equipments for routine sample analysis (e.g., HPLC, UPLC, Mastersizer, Zetasizer, UV-VIS Spectrophotometer, Karl Fisher titrator etc.)•Compiled and reviewed Stability Data for Regulatory Submission.•Coordinated with F&D department for routine activity.•Prepared and reviewed Method Development Report, Standard Test Procedure, Certificate of Analysis and Specifications for Tech Transfer.•Maintained stability records for investigation of OOS and OOT results.•Observed and complied with Good Documentation Practice (GDP).

Vadodara Area, India

•Developed and validated analytical methods for Injectables, Liposomal Formulations, Suspensions and Admixtures.•Responded in timely submission of USFDA queries. •Prepared and reviewed technical writings like Method Development Report, Standard Test Procedure, Certificate of Analysis and Specifications for Stability Analysis.•Analyzed various Injectables, Liposomal Formulations, Suspensions and Solid orals routine and stability samples.•Troubleshooting of Analytical Methods for stability analysis.•Operated instruments like HPLC, UPLC, Mastersizer, Zetasizer, Dissolution Apparatus, UV-VS Spectrophotometer, Karl Fisher titrator.

Ahmedabad, Gujarat, India

•Developed analytical method for finished drug products & drug substances.•Successfully performed method development in CHIRAL HPLC for separation of Isomeric Compounds.•Used HPLC for monitoring of reaction intermediates.•Analyzed samples using GC, LCMS, MASS, POLARIMETER & KARL FISHER.•Successfully calibrated HPLC on quarterly basis.•Interpreted and adhered to strict guidelines on documentation when recording routine and developmental data.

Vadodara Area, India

• Analyzed and developed method for finished drug products.•Extracted samples and quantified them with respect to reference standards (Sigma Aldrich) using HPLC.•Performed qualitative and quantitative analysis of various organic compounds, chemicals using derived methods or developed methods on HPLC & GC.•Carried out analyses on equipments like FTIR, Karl Fisher, and Polarimeter.

Master’S Degree, Medicinal And Pharmaceutical Chemistry, First Class

Activities and Societies: Design, Development and Biological Evaluation of Pyrimidinylmethylsulfinylbenzimidaozle as Novel Anti-Ulcer.

Bachelor’S Degree, Pharmacy, Distinction