Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Dir. QC Technical Resources

  • Jan 2023 - Present

• Assoc. Dir. QC Technical Resources

  • May 2021 - Dec 2022

• Sr. Manager QC Technical Resources

  • Sep 2019 - Apr 2021

• Staff Scientist

  • Jan 2018 - Aug 2019

• Senior Scientist

  • Jan 2016 - Dec 2017

  • Co-ordinate with members of process analytical sciences, manufacturing, stability and business operations to provide analytical support • Manage Scientists, distribute work and monitor progress • Review summary reports when approving method validations and method transfers • Review updates in regulatory requirements and ensure that test methods and policies are in compliant with current regulatory guidelines • Provide technical support in Regulatory inspections and present QC… Show more • Co-ordinate with members of process analytical sciences, manufacturing, stability and business operations to provide analytical support • Manage Scientists, distribute work and monitor progress • Review summary reports when approving method validations and method transfers • Review updates in regulatory requirements and ensure that test methods and policies are in compliant with current regulatory guidelines • Provide technical support in Regulatory inspections and present QC methods and method validations to inspectors as necessary • Point person for technical troubleshooting and investigations • Review scientific submissions and provide responses to the questions from regulatory agencies • Perform assay development for QC Chemistry group and Raw Material Testing group • Review new test procedures and assays, stability protocols for Regeneron products and Comparators • Assess the proposed changes in procedures and product specifications • Evaluate and bring in new methodologies/techniques – developed and implemented Raman Spectroscopy as an identification method for raw materials at Regeneron and FT-IR microscope to identify micron size foreign particles in the products • Train analysts on new methodologies and technologies. • Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance. • Maintain integrity by working on research projects in GMP environment

• Scientist

  • Oct 2013 - Dec 2015

  • Perform assay development/validation for QC Chemistry group and Raw Material Testing group. • Review new test procedures and assays, stability protocols for Regeneron products and Comparators (SME). • Evaluate and bring in new methodologies/techniques – developed and implemented Raman Spectroscopy as an identification method for raw materials at Regeneron and FT-IR microscope to identify micron size foreign particles in the products • Coordinate with members of process analytical… Show more • Perform assay development/validation for QC Chemistry group and Raw Material Testing group. • Review new test procedures and assays, stability protocols for Regeneron products and Comparators (SME). • Evaluate and bring in new methodologies/techniques – developed and implemented Raman Spectroscopy as an identification method for raw materials at Regeneron and FT-IR microscope to identify micron size foreign particles in the products • Coordinate with members of process analytical sciences, manufacturing, and stability to provide analytical support. • Review updates in regulatory requirements and ensure that the test methods and policies are in compliant with current regulatory guidance. • Train analysts on new methodologies and technologies. • Participate in technical troubleshooting and problem investigation. • Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance



Memorial Sloan Kettering Cancer Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Research Fellow

  • Feb 2012 - Sep 2013

  Formulation and Evaluation of different salts of the lead compounds to increase water solubility and preclinical studies. Metabolic stability, PK/PD profile, Partition Co-efficient and Plasma protein binding studies of the synthesized compounds using LC-MS. Performed preclinical studies overseeing translation of anticancer agents into clinic. Designed, synthesized and evaluated compounds for biological activity as modulators of Hsp70 and Hsp90. Designed and synthesized… Show more Formulation and Evaluation of different salts of the lead compounds to increase water solubility and preclinical studies. Metabolic stability, PK/PD profile, Partition Co-efficient and Plasma protein binding studies of the synthesized compounds using LC-MS. Performed preclinical studies overseeing translation of anticancer agents into clinic. Designed, synthesized and evaluated compounds for biological activity as modulators of Hsp70 and Hsp90. Designed and synthesized biotinylated and FITC probes for Hsp90 and Hsp70 to better understand the biology of these targets. Show less Formulation and Evaluation of different salts of the lead compounds to increase water solubility and preclinical studies. Metabolic stability, PK/PD profile, Partition Co-efficient and Plasma protein binding studies of the synthesized compounds using LC-MS. Performed preclinical studies overseeing translation of anticancer agents into clinic. Designed, synthesized and evaluated compounds for biological activity as modulators of Hsp70 and Hsp90. Designed and synthesized… Show more Formulation and Evaluation of different salts of the lead compounds to increase water solubility and preclinical studies. Metabolic stability, PK/PD profile, Partition Co-efficient and Plasma protein binding studies of the synthesized compounds using LC-MS. Performed preclinical studies overseeing translation of anticancer agents into clinic. Designed, synthesized and evaluated compounds for biological activity as modulators of Hsp70 and Hsp90. Designed and synthesized biotinylated and FITC probes for Hsp90 and Hsp70 to better understand the biology of these targets. Show less