Savita Sharma

Principal Scientist Ii, in Vitro Adme @Charles River Laboratories

Worcester, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2022 — Present

Principal Scientist Ii, in Vitro Adme @Charles River Laboratories

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Worcester, MA, US

Working Site: Charles River Laboratories, Worcester, MA• Function independently as a Principal Investigator and technical expert with the aim of developing, performing, and troubleshooting bioanalytical laboratory experiments, tests, and procedures within accepted regulatory compliance (i.e, ICH M12 and FDA).• Serve as the primary contact for planning and executing sponsor interactions related to research and method development for the design, scheduling, conduct, and reporting of in vitro and in vivo ADME studies.• Provide oversight of laboratory work and mentor scientific staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation. • Provide scientific expertise in study conduct, design, and interpretation.• Brought in and modified a variety of CYP450- and non-CYP450-based assays, including DDI, phenotyping for FMOs, MAOs, NATs, and UGTs, inhibition for MAOs and UGTs, metabolic stability for AOs and XOs, and GSH trapping. • Ensure that raw data is accurate, complete, and in appropriate order to meet protocols, SOP specifications, and GLP requirements.• Prepare high quality final reports for studies requested by clients that are readily available for IND filing and outline details, such as method development, qualification, and sample analysis specifications.• Perform advanced troubleshooting on analytical instrumentation including chromatography and mass spectrometry systems.• Direct the development and communication of departmental systems, SOPs, policies and procedures.• Attend and present at scientific meetings.• Perform all other related duties as assigned.

EDUCATION

N/A

Delhi University

Doctor of Philosophy - PhD, Inorganic Chemistry

1998 — 2001

Delhi University

Bachelor's of Science, Chemistry (Hons)

N/A

Delhi University

Master of Science - MS, Organic Chemistry

ABOUT SAVITA SHARMA

Experienced Scientist who is highly skilled in managing multiple research projects with a diverse background in inorganic, organic, analytical, and biological chemistry. • Expert at biological assay development, method optimization and validation, and in-vitro ADME and PK analysis.• Master user of LC-MS/MS Quantitative Bioanalysis and qualitative Metabolite identification (Agilent Triple Quad G6460C, Thermo Orbitrap-Masslynx, Xcalibur), Surface plasmon Resonance (SPR), iTC, NMR, EPR, UV-Vis, HPLC, • Master user of Transepthelial/transendothelial electrical resistance (TEER) measurement.• Expert in techniques such as transient transfection, HTS screening (Fluorescence, Luminescence, and UV-Vis readout), and data analysis (Prism Graphpad, Phoenix WinNonlin, Excel, Origin software).• Master collaborator capable of working on multi-disciplinary research projects and setting up relationships with various business partners and instrumental and chemical industries.

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Savita Sharma — Principal Scientist Ii, in Vitro Adme at Charles River Laboratories in Worcester, MA, US | Unifers