Experience

Adare Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Analytical Scientist III

  • Dec 2022 - Present



Liberty pharma Inc

• Kansas City, Missouri Area

• Senior Research Associate

  • Jun 2016 - Dec 2022

  -Performed quality control and R & D testing of raw material, in-process material, finished products, commercial products, stability samples in compliance to FDA, cGMP, ICH and OSHA guidelines -Performed method development, method validation and method verification, cleaning validation on various analytical procedures for drug substances as well as drug products -Handled resolution of all product quality issues including deviations, incidents, investigations (OOT, OOS) and CAPAs pertaining to material testing -Prepared and reviewed all written procedures such as change controls, SOPs, specifications, analytical standard test methods, protocols, analytical validation and verification reports, certificate of analysis, stability summaries and ARF’s -Good Knowledge in understanding the chemistry of a molecule, literature search for existing methods and execution/verification of the compendial methods as per USP. -Conducted FDA, DEA and client interaction -Organized internal audit programs and assisted with client cGMP Audit and evaluation and qualification programs. -Collected and maintained stability data from initial release to 36-month duration -Proficient in operating, troubleshooting, maintaining, and calibrating various analytical instruments like, HPLC, GC, FTIR Spectrometer, Sieving Machine, Air Jet, Tapped Density Tester, Texture Analyzer, Malvern Mastersizer, HC2-AW USB Water Activity & Temperature Probe, Dissolution apparatus (I, II, Paddle over disc), KFT, AcuSeal and Bulk Density tester -Performed installation, operational and performance qualification of analytical instrument and reviewed calibration and qualification documents -In-depth knowledge of software like Agilent Open Lab CDB EZChrom, Visibar, Fourthshift -Trained, assigned, organized work and overseen duties of colleagues -Handled DEA/controlled substances, drug products, reagents, and chemicals -Supported regulatory filing and review -Coordinated QC testing with contract affiliations Show less



Long Island University

• United States
• Higher Education
• 700 & Above Employee

• Graduate Student

  • Jan 2014 - May 2016

  "Screening and Characterization of Polymorphic Form III of Febuxostat” Long Island University, Brooklyn, NY - Generated polymorphic form III of Febuxostat by antisolvent and evaporation method - Performed qualitative and quantitative analysis of polymorphic form III of Febuxostat by XRPD, IR, HPLC and DSC techniques - Studied and analyzed the effects of controlled variables (temperature, pressure, and solvents) on form III of Febuxostat Show less