Munish Kumar Email & Phone Number

Munish Kumar is a Manager, Analytical Research and Development at Formel Labs Pvt Ltd.

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  Manager, Analytical Research And Development

  Formel Labs Pvt Ltd

  Oct 2021 - Present - Pragathi Nagar, Kukatpally Hyderabad

  Presently working as a Manager in ARD and overall responsible to ensure on-time and all-time analytical support by HPLC, GC, LCMS and by other analytical instrument. Handle and manage the work for ARD team of 18-20 People.Low level detection and quantification for Genotoxic and Nitrosamine impurities by techniques like LCMS, GCMS, HPLC and GC. Identification of unknown compounds and structure elucidation using LCMS and GCMS.Lead the section of Method development, Routine analysis and LCMS by HPLC, UPLC, LCMS.Analytical method development and validation (including related substances and assay by HPLC for finished APIs, chromatographic purity by HPLC for intermediate stages) and in-process testing. Low level detection and quantification for Nitrosamine impurities in APIS by techniques like LCMS, GCMS. Nitrosamine impurities testing in various APIs (Plant samples) by LCMS, GCMS, Validations of APIs, Intermediates, RMs by HPLC, LCMS. Routine Analysis, for various products like FINAL API, INTERMEDIATE, RAW MATERIAL by HPLC, LCMS, & UPLC. Preparation and review of STPs, SOPs, Method development reports, Validation reports and protocols. Investigation of lab incidents and deviations. Root cause identification, corrective and preventive action for lab incidents and deviations. Addressing customer and regulatory queries. Calibration of various Analytical instruments in the lab. Instrument troubleshooting HPLC,UPLC,LCMS,(Q-TOF and TQS-Micro) To implement and ensure all c GMP/c GLP compliance during Analysis. Review and Preparation of COA, routine analysis data, protocols and reports. Impart training and seminars to new joiners and other ARD persons on various topics. Isolation and purifications of known and unknown impurities from PREP HPLC and its identification by HPLC and MASS. Review of log books and lead the column management team. Perform all Analytical Method development, Genotoxic study, Regulatory quarry by LCMS, & HPLC.

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  Gndu Amritsar

  Pharmaceutical Sciences