Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Apoorva Sharma

Senior Research Associate
Mumbai

Summary

Senior Research Associate specialized in setting project objectives, creating experimental plans, and prioritizing tasks for timely delivery. Serves as the main contact for executing mAbs, gene therapy and peptibody biosimilar research projects and communicating findings to leadership. Proficient in written and oral communication for presenting complex analyses effectively.

Overview

9
9
years of professional experience
15
15
years of post-secondary education

Work History

Senior Research Associate

USV Pvt Ltd.
10.2022 - Current
  • Method development of JAK2 STAT5 kinase for a peptibody biosimilar followed by its qualification led to the swiftly developed potency assay
  • Cost effective development of a clone screening ELISA for a mAb biosimilar led to the selection of high yielding clones for maximum production of the product. Guided sample analysis of approximately 4000 clone samples which resulted in the selection of top 5 high performing clones for the project. Worked with cross-functional project teams for the clone selection
  • Completion of bio-similarity study with 3-6 US and EU RMPs for peptide and peptibody pipeline molecules for EMA submissions. Data generation from execution of potency assay, bioassay and ligand binding ELISA
  • Troubleshot instrumentation issues, ensuring minimal downtime for critical experiments
  • Periodic revision of SOPs, annual PM and calibration of lab equipment and instruments as per SOPs
  • Routine end to end QA reviews under strict compliance

Associate Scientist

Intas Pharmaceuticals Ltd.
08.2021 - 09.2022
  • Developed bioassay for HEK293 transfection by AAV6/AAV8 for protein expression of FVIII/FIX followed by quantification through ELISA
  • TAb (Total Antibody) assay AAV6 method development and qualification as pre-clinical study
  • Conducted experiments AAV6 anti-VEGF scFv stability study led to RCGM submission
  • EOP based performance verification of Lab equipments. Critical reagent inventory maintenance resulted in efficient and cost effective lab management
  • Trained newly hired employees on processes and procedures relevant to lab tasks at hand
  • Regular data presentations and standard developmental procedure, MDR, MQP and MQR preparation
  • Brief method development for RT-PCR preclinical study
  • Technical training to subordinates and trainees


Senior Scientist

Biocon Biologics Ltd.
07.2019 - 08.2021
  • Executed sample analysis for Proliferation inhibition assay of MDAMB-165-VII, dimerization inhibition assay of Her2-Her3 binding and Her2 binding indirect ELISA for a mAb biosimilar
  • Method development and qualification of proliferation inhibition assay of HUVEC followed by report preparation
  • Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.

Research Associate

Dr. Reddy's Laboratories Ltd.
09.2016 - 06.2019
  • Performed, evaluated and documented analytical similarity, stability and comparability sample analysis for functional assays (CDC and ADCC) and ligand binding ELISA (C1q, FcγRIa, FcγRIIIb, FcγRIIa, FcγRIIb) for Rituximab
  • Handled cell lines and primary cells ( isolation, banking freezing, thawing, propagation, testing)
  • Method development and qualification of proliferation assay and Clq indirect binding ELISA for mAb biosimilar
  • Estimation of process related impurities such as HCP, HCD & Protein A Leachate for in-process samples by kit based method

Education

Master of Science - Medical biotechnology

Maharaja Sayajirao University of Baroda
Vadodara
04.2001 - 01.2016

Skills

Cell lines and primary cells - isolation, banking, freezing, thawing, propagation and assay

Monoclonal antibody biosimilars, peptides and Gene therapy products

Spectramax i3x, Gen 5 304, PLA 30

Scientific troubleshooting

Mentorship to trainees and subordinates

Cell based assay and ELISA

Accomplishments

    Recognition award 2024, USV Private Limited

    Avengers Award 2022, Intas Pharmaceuticals limited

    Stellar performer 2019, Dr.Reddy's Laboratories

    Gate 128th AIR, 2016

Timeline

Senior Research Associate

USV Pvt Ltd.
10.2022 - Current

Associate Scientist

Intas Pharmaceuticals Ltd.
08.2021 - 09.2022

Senior Scientist

Biocon Biologics Ltd.
07.2019 - 08.2021

Research Associate

Dr. Reddy's Laboratories Ltd.
09.2016 - 06.2019

Master of Science - Medical biotechnology

Maharaja Sayajirao University of Baroda
04.2001 - 01.2016

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Apoorva SharmaSenior Research Associate