Nilesh Dumbre

Organized and dependable candidate HAVING 15 years of experience successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Impurity profiling and quantification of impurities i.e. genotoxic, NDSRI by LCMS technique.
• Unknown peak identification, out of specification and out of trend investigation by LCMS technique.
• Development of HPLC methods like Assay, Related substances for raw material, intermediates and API including genotoxic Impurities.
• Prepare method development and control strategies by discussion with RnD and regulatory department.
• Prepare and check readiness of analytical data for DMF submission to regulatory department.
• Review of routine, complete analysis and validation reports.
• Perform method verification study and analytical method transfer to unit QC.
• Routine Analysis of raw material, Intermediates and final API as per Pharmacopoeia and in-house methods.
• Perform calibration of HPLC Instruments.
• Preparation of method of analysis and specification.
• Executing processes in accordance with cGMPs, USP/NF/BP/EP compendia and standard operating procedures, maintaining various key documents, logbooks, databases and notebooks in compliance with cGMPs and Updating and maintaining entries in laboratory notebooks and analytical records/reports to assure that calculations, content and references are technically correct.
• Directing, leading & motivating junior team members and trainees for work effectiveness / efficiency
• Focus on performing work efficiently by following GLP and safety.
• Exceptionally well organized and detail-oriented with capability to meet deadlines
• Holds competencies in implementing various quality standards and techniques for improving the project operations along with cost savings

• Date of Birth: 07/19/82
• Nationality: Indian
• Marital Status: married

• LC-MS
• HPLC
• FT-IR
• UV spectrophotometer
• KF Apparatus
• Gas Chromatography