Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Languages
Timeline
Generic

Bharti Pandey

Clinical Reseach and Health care
Toronto,Canada

Summary

Experienced and detail-oriented Scientist with a Ph.D. in Applied Sciences (Virology) and over 10 years of progressive experience in academic and clinical research. Proven expertise in cell therapy, assay development, molecular diagnostics, regulatory compliance (ICH-GCP, FDA, Health Canada), and data integrity. Adept at driving research innovation, managing cross-functional collaborations, and translating data into strategic decisions. Passionate about contributing to cutting-edge therapies that improve patient outcomes.

Overview

18
18
years of professional experience
6
6
Certification

Work History

Cell and Gene Therapy Specialist

Princess Margaret Cancer Centre
08.2022 - Current
  • Designed and executed cell therapy research studies with focus on quality, integrity, and regulatory compliance.
  • Managed oncology clinical trial documentation and ensured alignment with FDA and ICH-GCP standards.
  • Conducted detailed data analysis and recommended improvements to research protocols.
  • Coordinated with investigators, clinical staff, and sponsors to ensure project deliverables and compliance.
  • Facilitated audits and regulatory inspections; supported investigational product handling per TDG.
  • Generated reports detailing findings and recommendations.

Senior Research Scientist

ESIC Medical College & Hospital
09.2020 - 03.2022
  • Led multiple clinical research projects from initiation through close-out, ensuring GCP compliance.
  • Reviewed study protocols, CRFs, and regulatory documentation, supporting IRB submissions and ethics compliance.
  • Trained research staff and coordinated with interdisciplinary teams to meet clinical milestones.
  • Published numerous high-impact research articles in prestigious journals, elevating the lab''s reputation within the scientific community.
  • Optimized laboratory protocols for increased accuracy and reproducibility of results.
  • Streamlined processes for improved efficiency, resulting in accelerated project completion rates.
  • Implemented cutting-edge technologies to streamline workflows and enhance data quality.

Research Officer

National AIDS Control Organization
05.2018 - 09.2020
  • Oversaw the national HIV Sentinel Surveillance project; managed logistics, training, and data coordination.
  • Ensured regulatory and ethical adherence across field operations and stakeholder engagement.

Senior Research Officer – Scientist C

AIIMS
08.2012 - 03.2017
  • Applied molecular diagnostics techniques (PCR, rRT-PCR, TAC) in respiratory virus detection.
  • Performed cell culture, ELISA, and virology assays; led manuscript development and annual reporting.

Senior Research Officer – Molecular Diagnostics & Clinical Research

AIIMS
03.2007 - 07.2012
  • Developed and validated diagnostic assays for clinical research; conducted high-level molecular biology protocols (blotting, immunoassays, PAGE).
  • Contributed to protocol development, data analysis, and cross-team scientific collaborations.

Education

Ph.D. - Applied Sciences (Virology)

All India Institute of Medical Sciences
01.2017

M.Sc. - Biochemistry

Dr. B.R. Ambedkar University
01.2003

B.Sc. - Science (Zoology, Botany, Chemistry)

Dr. B.R. Ambedkar University
01.2001

Skills

  • Experimental Design & Execution
  • Molecular & Cell Biology Techniques
  • Assay Development & Validation
  • Regulatory Compliance (FDA, ICH, Health Canada)
  • Data Analysis & Interpretation
  • Cross-Functional Collaboration
  • Project Management
  • Scientific Communication & Reporting

Certification

  • ICH-GCP (Good Clinical Practice)
  • Health Canada Division 5
  • Good Laboratory Practices (GLP) & Good Documentation Practices (GDP)
  • TDG (Transportation of Dangerous Goods) | Knowledge of IATA Standards

Accomplishments

  • Supervised team of 18 staff members.

Languages

English
Advanced (C1)

Timeline

Cell and Gene Therapy Specialist

Princess Margaret Cancer Centre
08.2022 - Current

Senior Research Scientist

ESIC Medical College & Hospital
09.2020 - 03.2022

Research Officer

National AIDS Control Organization
05.2018 - 09.2020

Senior Research Officer – Scientist C

AIIMS
08.2012 - 03.2017

Senior Research Officer – Molecular Diagnostics & Clinical Research

AIIMS
03.2007 - 07.2012

M.Sc. - Biochemistry

Dr. B.R. Ambedkar University

B.Sc. - Science (Zoology, Botany, Chemistry)

Dr. B.R. Ambedkar University

Ph.D. - Applied Sciences (Virology)

All India Institute of Medical Sciences
Bharti PandeyClinical Reseach and Health care