Description
SUMMARY OF QUALIFICATION An accomplished research professional with excellent communication skills who is organized, detail oriented and a team player. Has over 21 years of experience and extensive background that includes leadership role in analytical research in many reputed pharmaceutical organizations. KEY AREA OF EXPERTISE Lead and supervised a team of scientists to execute analytical method development, method validation & stability studies. Develop robust and effective stability indicating methods of analysis for API and drug product. Effectively executed analytical method validation work. Prepare analytical method validation protocol and reports per ICH/regulatory requirements. Designed and planed stability study for the projects. Prepare, review and implement in-house guideline and SOPs as per regulatory requirements. Managed resources and use of personal time to ensure timely and responsive efforts on all the projects. Direct activities for the technology transfer to production unit. Complete laboratory investigation. Work directly with CROs and CDMOs to develop, validate and transfer stability indicating analytical methods. Involve in investigation Out of Specification (OOS) and Out of Trend (OOT) analysis. Perform calibration of various analytical instruments. KNOWLEDGE OF ANLAYTICAL INSTRUMENTS * UPLC : Waters * RRLC : Agilent Technologies * HPLC : Waters, Shimadzu, Perkin Elmer * LC - MS : Waters, MicroMass-ZQ, QTOF * GC & GC-HS : Shimadzu, Agilent * Preparative LC : Waters * Particle Sizer : Malvern & Horiba * Dissolution apparatus : Venkel, Distek, Lab India (Apparatus I, II, III, IV, V and VI) * HPTLC : Camag * FT-IR : Perkin Elmer, Shimadzu * Polarimeter : Shimadzu, Jasco * UV - Vis spectrophotometer : Shimadzu, Perkin Elmer * Autotitrator : Metrohm, Mettler Toledo * Atomic Absorption Spectrophotometer : Shimadzu AAS 7000 * Tensile strength tester : Instron 5943 * SEM : Hitachi * EDS : Thermo Fisher * Stereo Microscope : Nikon SMZ800 and * DSC : Mettler Jigneshkumar I. Desai KNOWLEDGE OF COMPUTER AND ANALYTICAL ACQUSITION SOFTWARES * Knowledge of Microsoft Office i.e. MS Word, Power point and Excel. * Knowledge of statistical data preparation using Microsoft excel. * Experience on Waters Empower2 & 3 software, Empower2 & 3 software validation, custom calculations and its validation. * Familiar with waters LC-MS software UNIFI.
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