Nitin Patil
Manager R&D Analytical @ Unichem Laboratories Limited
About
Senior Analytical R&D professional with 17+ years of experience in API analytical development, reference standards, impurity characterisation, solid-state chemistry, and regulatory (DMF) support, gained in USFDA-inspected pharmaceutical environments. Currently working as Manager – Analytical R&D at Unichem Laboratories Ltd., where I lead a 6-member Reference Standards team. My responsibilities include qualification, lifecycle management, and regulatory compliance of in-house reference standards, advanced spectroscopic characterisation (¹H/¹³C/2D NMR, LC-MS, FTIR, UV), solid-state & polymorphism studies (XRPD, DSC, TGA), and HPLC/UHPLC method development. I have strong hands-on experience with GMP, QMS, deviations, CAPA, change control, audit readiness, and interacted with USFDA auditors. I regularly support DMF submissions, regulatory responses, and CMC analytical activities.
India
Goa
Pharmaceuticals
Manufacturing, Team Building, Team Management, Team Leadership, Pharmaceutical Testing, Laboratory Skills, Problem Solving, Troubleshooting, Standard Operating Procedure (SOP), Time Management, Communication, NMR, HPLC, Medicinal Chemistry, SciFinder, Organic Chemistry, IR, Characterization, Purification, Regulatory Requirements
Experience
Manager R&D Analytical
Unichem Laboratories Limited
North Goa, Goa, India
Unichem API analytical Team lead. Method development ,Validation , Review and approval of STP & specification,Analytical reports, Procurement & Upgradation of new instrument IQ OQ PQ review.DMF submission. Preparation of protocols, new SOPs. QMS documentation Event Deviation CCP investigation CAPA audit compliance etc. responsible for IR NMR DSC TGA HPLC PREP Cooling chember, lab safety and Good documentation practices.
Research Scientist-II
Unichem Laboratories Limited
COE Goa
Leading reference standard characterization team (7) and responsible for planning and execution of in-house references standard qualification and provide STD support to all Unichem locations to meet development, Validation , TT and API & Finished product release testing requirements. Acts as technical resource for application maintenance & theory of instrument viz NMR HPLC prep-HPLC XRPD UV IR DSC TGA. Standard Operation training, presentations, GDP, s/w administrator (Empower 3, Spectum ES 10, Delta5.1,CaryWin UV,DAMS,Pyris etc) new instrument procurement (technical sameness cost comparison demos) Handling event Deviation CCP, CAPA recommendation and implementation. DMF ANDA Establish Specification for reference standard. Installations FTIR DSC TGA UV Up gradation Empower 3, windows 10
Research Scientist-I
Unichem Laboratories Limited
North Goa, Goa, India
• Executed Characterization activity of Impurity, intermediates raw material reference standards. • Performed API stability and release plant batch analysis by DSC & XRPD. • Performed Thermal analysis (DSC TGA study) for stability and polymorphism of APIs. • Identification, Isolation & characterization of unknown impurities generated in API Rout of synthesis at plant by Reverse phase PREP HPLC and mass spectroscopy. • Responsible for NMR analysis & qNMR, Direct mass & LCMS analysis • Performed Qualification of Reference standard & Identification by spectroscopic techniques.
Research Executive
Unichem Laboratories Limited
Pilerne, Goa, India
Executed Characterization activity of inhouse referance standards. Responsible for NMR analysis of all API inprocess samples by proton carbon 2D NOE HMBC VT experiments API stability and release testing by DSC & XRPD. Thermal analysis DSC TGA and method developmemt for polymorphism of APIs. identification of unknown impurities in API release and finish LCMS analysis of inprocess, intermediate and final drug samples. carryover study of impurities by ION Chromatography.
Research Fellow
Emcure Pharmaceuticals Limited
API RESEARCH CENTER Hinjewadi Pune
Responsible for NMR analysis of impurities, intermediate and final active pharmaceutical ingredients by 1D 2D NMR, variable temp experiments. Spectral interpretation, Characterization, DMF submissions
Research Chemist
Sai Life Sciences Ltd
Hinjewadi Pune
Analysis of newly designed synthetic molecules,Library molecules. Detection of m/z ration of new chemical entities. purification and isolation of unknown compounds by prepHPLC. 1H 13C F19 COSY NOESY HSQC HMBC dynamic NMR qNMR study of organic compound on 9.3T Varian NMR spectrometer. Purity analysis of NCE's by reverse phase Analytical HPLC
Education
Shivaji University
Chemistry
Nitin Patil's Contact Information
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