To synergize my work with the company’s motto and be in an organization where I can use my analytical chemistry knowledge and research skills to add value to the business as well as nurture talent in a highly competitive work environment.
An inquisitive analytical scientist with >10 years of industrial experience in Chemical and pharmaceutical field and proven ability to advance drug discovery and drug development projects. Strong expertise in mass spectrometry based characterization and quantitation for solving problems related to small molecules. Expert in chromatographic method development and validation using HPLC (UV/MS) and GC. Proven record in polymorph characterization.
Spectrometry : Small organic molecules structure elucidation and impurity profiling by Accurate Mass QToF- LC-MS, MS/MS, GCMS, NMR (1D,2D), FTIR.
Chromatography : U/HPLC, GC Method development and Validation by U/HPLC, GC based on ICH guidelines and QbD principles.
Stability studies: Accelerated stability and degradation studies of DP/DS and impurity profiling by Mass Spec.
Trace level analysis : Sub ppm level analytical method development for Genotoxic impurities, Extractable and Leachable by LC-MS/MS, GC-HS-MS.
Solid State : Quantitative and qualitative characterization of Polymorphs by XRPD,DSC, TGA, DVS, Malvern PSD, Scanning Microscope.
Prep HPLC : Isolation and characterization of impurities by Prep HPLC.
• Started a structure elucidation and Genotoxic impurity lab, installing QTOF-MS, LC-MS/MS, NMR. Identification and characterization of impurities in many NCE’s , Terbutaline Sulphate (DS/ Syrup) , Tofacetanib, Prostaglandins.
• Ppb level genotoxic impurity analysis method developed and validated for Fostamatinib, Halo Anilines, Boronates in API using LC-MS/MS, GC-HS-MS.
• Analytical methods (HPLC/UPLC) developed and validated for about 15 Phase-II and 4 Phase-III projects and 2 Late stage projects as per ICH guide lines ( QbD).
• Installed and qualified a solid state lab, XRPD,DSC,TGA, DVS as per GMP/GLP.
• Success full guidance to 10 Postgraduates and 2 PhD Students for their industrial research- Resulted tw0 Papers in International Journals.
• Faced Global Quality and Safety audits and certified.
• Part of Global Mass Spec specialists group of AstraZeneca UK
• Best Scientist Award (2012), Employee of the year (2013), Best project awards (2009, 2010, 2011, 2012, 2013). 4 Scientific papers on international journals.
• Trainer for Advanced Mass Spectrometry, HPLC Method development, ACD LAB LC Stimulator, Structure Elucidator.
Analytical Chemist – VMPS- Pfizer Pharmaceuticals Pvt Ltd, Mumbai
Sep 2006– Aug 2008.
• Set up and qualified a new analytical lab for CRD support- NMR, LCMS/MS, UPLC, GCMS, XRPD, DSC, TGA, PREP LC
• SOP’s, WoW, Training to Process Chemists for instrumentation completed.
Analytical Scientist– Torrent Pharmaceuticals (I) Ltd, Ahmedabad
Nov 2004– Sep 2006
• Built a solid state lab- XRPD. Faced USFDA audit for Sertraline HCl, Metformin HCl , passed without any majour deviation
• Isolation and characterization of new impurities in Clopidogrel, Ondansetran.
• Quantification methods developed and validated for Polymorphs of Sertraline, Clopidogrel, Atorvastatin in DS and DP
• Planned and controlled a revenue budget of INR 2.0 Crore as part of Project management without any deviation.
Chemist – Quality Assurance– Asia Paints (I) Ltd, Ankleshwer
Jan-2000– Nov 2004
• Quality Assurance of Raw materials (Additives, pigments, Solvents and Veg oils) intermediates (Resins, Emulsions) by Physico Chemical and Microbiological analysis.
• Best employee award 2002, 2004
Chemist – Quality Control– Rhone Poulenc , Ahmedabad
Nov 1997– Dec 1999.
• Physico Chemical and Microbiological QC of Food / Pharma grade guar gum.
• 1995-1997 – M Sc Chemistry- 70% Marks -Gold Medal Winner.
• 1992-1995 – B Sc Chemistry – 79% Marks
• 2003-2005- PGDBA – Symbiosis Pune.
• 1999-1999- Certificate Course in Computer systems