Hardik
Objective To obtain a Research Scientist position in Pharmaceuticals Research where I can utilized my training and experience of Analytical Method Development and Validation of ANDA, NDA Products, Under GLP and cGMP
Work experience
January 2008- July 2008 Alembic Research Center Gujarat, India
Research Associate (Analytical Development Lab- F&D)
• Development of various analytical methods of ANDA products including Assay method, Dissolution method of Finish products using UPLC, HPLC, Dissolution, UV and FTIR.
• Analysis of raw materials, compatibility study samples, in process, finished products and analytical sample under GLP.
• Dissolution profiling for abbreviated new drug application.
• Validation of analytical method of finish product as per guidelines of regulatory.
May 2005- December 2007 Cadila Pharmaceutical Ltd, Gujarat, India
Analytical Chemist (Technical Supervisor) –Analytical Research Lab-F&D
• Development of Finished products for export markets.
• Validation of Analytical method of finish products for USFDA, TGA etc., audits
• Preparation and review of protocol and reports for validation as per guideline of regulatory markets and also for audit.
• Calibration of sophisticated Analytical Instruments like HPLC, Dissolution etc.,
• Preparation, review and implementation of Standard Operating Procedures for analytical laboratory under GLP guidelines
Education
M. Sc (Chemistry) S.P. University, Gujarat India 4/2005
B. Sc (Chemistry) Gujarat University, Gujarat India 4/2003
Associates in Science, Gujarat Secondary Education Board, Gujarat India 3/1999
Instruments
Handled
Skills and Application Instrument Name Make
• HPLC and UPLC Waters – Alliance (Empower),Shimadzu
Agilient , Dionex(Chrome Leon Soft.)
• Gas Chromatography Perkin – Elmer
• Dissolution Apparatus (Type – I, II, III) Varian, Electro lab, Lab India.
• Infrared Spectrophotometer (FTIR) Perkin – Elmer, Shimadzu.
• UV- Visible Spectrophotometer Shimadzu.
• Auto Titrator / KF Titrator Mettler, Spectra Lab
• Good Command over development of Analytical Method of Assay of finished products.
• Good Command over operations and also troubleshooting of sophisticated Instruments.
• Exposure in Empower with 21 CFR software, and also good command over My SAP.
• Development of In house analytical method to reduce analytical expenditure.
• Good knowledge in cGMP and also GLP
Computer
Skill
Internet, Microsoft word, Microsoft Excel, Power point, Comfort on Microsoft Windows 9x/2000/NT/Me/XP, My SAP-4, Good Knowledge of Hardware and Desk top publication,
Relevant Courses
Basic Research, Analytical Method Development like Assay method, Residual Solvent method,
Related substance method, Dissolution method. Analytical Method Validation of Finish products
Compatibility studies and Stability studies during the development of new products
References Personal and Professional References will be available upon request.