Dnyanoba Madrewar

Pharmacist and with 9+ years of solid working experience in different fields of mass spectrometry including drug metabolism and pharmacokinetics, bioanalytical, toxicology, extractables & leachables and as application scientist.  Expertise in all kinds of LC-MS/MS and HRMS including Waters QTOF and ion mobility mass spectrometer.  Developed, optimized and validated many spectrometric methods for evaluation and quantification of Drugs, metabolites, peptides and Nitrosamines analysis using different kinds of LC-MS.  Impurities Identification of small peptides using QTOF HRMS.  Interpretation of peptide sequence and peptide chain modification by HRMS.  Proficient in handling and troubleshooting HRMS, triple-Quad instruments.  Method development and Screening of Nitrosamines for injectable formulation.  Result and team-oriented mindset with a proven ability to work effectively in a multi- disciplinary research environment  Effective communication skills. Presented posters and published articles in various journals. 

Perform Extractable and Leachable studies as per Internal SOP.  Method Development and Validation of different Extractable and Leachable compounds.  Prepare Elemental Risk Assessment reports, Leachable and Extractable Study reports for submission.  Impurity profiling of different compounds, Peptides, and Nitrosamine analysis using LCMSQToF (Waters Xevo G2-XS QTOF) using UNIFI Software.  Elemental analysis using PerkinElmers ICPMS NexIon 2000 for different drug products and drug substances.  Support in Method development using GC-MS/MS.  Handled Waters Ion mobility Mass spectrometry QTOF for isomeric peptide identification.  Identification of foreign particles in Injectables using RAPID and Keyence microscope. 

Method development, method validation and study sample analysis as per internal SOP based on USFDA, OECD and ICH guidelines to support regulatory studies using LC-MS/MS (AB Sciex and Waters).  Impurity Profiling using Mass Spectroscopy and Genotoxic Impurities Quantification.  Bio analysis of samples from various in-vitro and in-vivo studies using LC-MS/MS.  Proficient in use and troubleshooting of LC-MS/MS systems.  Usage of Phoenix® and Graph pad Prism® software to analyze and interpret the Pharmacokinetic/ Toxicokinetic data.  Performed analysis and evaluated data of clinical trials samples.  Preparation and review of bio-analytical method validation and study reports.  Served as a ‘Deputy Study Director’, responsible scientist to ensure that the studies are conducted in accordance with the study plan and applicable principles of GLP.  Audit faced USFDA and NGCMA 

Master's in Pharmacy in the subject of Pharmaceutical Analysis.  Passed in 2013 in first class.