Experience

Strides Pharma Inc.

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Principal Scientist

  • Oct 2023 - Present



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Analytical Scientist

  • Oct 2021 - Oct 2023



Par Pharmaceutical

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist (QC-LTS)

  • Mar 2019 - Oct 2021

  Provide method remediation/evaluation, method verification, method development, method validation, method transfer in production of generics leveraging industry knowledge and R&D expertise. • Serve as Senior Scientist in QC-LTS (R&D environment), following all regulatory compliance standards for FDA and current local, state, and federal laws.• Develop and validate methods for Assay, Dissolution, and related Substances/Impurities/ degradants using HPLC and UPLC powered by Empower 2 and 3 for Solid and Liquid Dosages.• Manage assigned projects and ensure project deadlines are completed.• Writing method development/validation/verification/transfer protocols and reports.• Serve as SME for Elemental Impurities Risk Assessment as per ICH Q3D guideline and USP requirement.• Troubleshooting Analytical procedures and instruments like HPLC, UPLC• Writing reports for USP <467> compliance. • Review notebooks and supporting documentation that supports daily lab activities assigned to staff. Show less

• LTS Chemist

  • Feb 2018 - Feb 2019

  Provide method remediation, method verification, method development and validation in production of generics leveraging industry knowledge and R&D expertise. • Writing method verification/validation/equivalency protocols and reports• Evaluation of USP monograph based methods for Assay and Impurities for Raw-Material and/or Finished Products• Verify/ validate/equivalent methods for Assay and related compounds/Impurities using HPLC, UPLC powered by Empower 3



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist

  • Feb 2007 - Dec 2017

  Provide method remediation, method development and validation in production of generics leveraging industry knowledge and R&D expertise. • Develop and deliver (SOP) Standard Operating Procedures on laboratory processes, policies and laboratory reports. • Prepare and review technical reports for residual solvent verification, elemental impurities verification, Assessment of manufacturer changes in API DMF. • Review notebooks and supporting documentation that supports daily lab activities assigned to staff. • Serve as lead Research Scientist in R&D development, following all regulatory compliance standards for FDA and current local, state, and federal laws. • Perform calibration and semiannual performance verification of instruments- HPLC, UPLC, UV-Vis, Dissolution • Develop and validate methods for Assay, related compounds using HPLC, UPLC, residual solvents using GC with Empower 2 and 3, elemental impurities using ICP-MS and Particle size determination using Malvern Mastersizer 2000 for all sites globally. • Test raw materials and in-processed samples utilizing general analytical instrumentation- HPLC, UPLC, Gas Chromatography (GC), ultra violet (UV), automatic titrator, IR, TLC, and dissolution testing that ensure quality standards are maintained. • Complete physical testing including particle size and thermal analysis, wet chemistry tests on samples including LOD, pH, and titration, and prepare standard/sample solutions needed for testing methodologies; performing needed calculations associated with test analysis. • Performing Elemental Impurities Risk Assessment as per ICH Q3D guideline and USP requirement • Writing reports for USP <467> compliance • Manage assigned projects and ensure project deadlines are completed. • Serve as Quality analyst to prepare annual product review, trend investigation and assessments of previously closed investigation as required per Company’s guideline, assessment of DMFs. Show less



AccuMed Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Chemist

  • Mar 2005 - Jan 2007

  Provide support on testing of In-Process and Finished product for release and stability. • Testing of in process and finished products for release and stability using instruments such as HPLC, IR, UV, FLUOROMETER, KF, DISSOLUTION and Thin Layer Chromatography. Documented all procedures and findings per FDA regulations. • Testing of solid, liquid and powder dosage as per USP for Loss on Drying, Loss on Ignite, Melting point, ID test for release. • Collected samples for TOC and micro samples for micro testing. Show less