Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
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Hemakshsi Pokiri

Summary

Results-driven biopharma research professional with expertise in regulatory compliance, clinical research, and study start-up processes. Strong background in phage display, protein purification, molecular biology, and enzymatic assays. Proficient in GMP, GLP, and ICH-GCP regulations, with experience in data analysis, protocol development, and site activation. Skilled in cross-functional collaboration to drive efficiency in regulatory submissions, ethics approvals, and trial start-up activities.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Postgraduate Researcher

University College Dublin
01.2022 - 09.2022
  • Led research on antibody screening and characterization using phage display technology in Escherichia coli
  • Conducted protein purification (IMAC, SEC) and antigen characterization using SDS-PAGE, ELISA, and Western Blotting
  • Optimized expression conditions for recombinant proteins and analyzed molecular interactions using fluorometric assays
  • Performed DNA sequencing and bioinformatics analysis to identify unique binders for therapeutic applications
  • Maintained regulatory compliance with Good Laboratory Practices (GLP) and documented findings per GxP standards

Research Associate Intern

Advanced Agricultural Research (AAR)
01.2021 - 09.2021
  • Managed site-level research activities, including protocol execution, sample processing, and data collection
  • Conducted fluorometric and microscopic assays to quantify fungal biomass in planta
  • Ensured regulatory compliance with GMP/GLP standards for sample handling and equipment maintenance
  • Presented weekly reports to senior management and regulatory stakeholders

Undergraduate Research Assistant

INTI International University
02.2019 - 05.2019
  • Developed novel antibacterial assays for analyzing methicillin-resistant Staphylococcus epidermidis
  • Assisted in HPLC, ELISA, and enzymatic analysis to assess drug efficacy

Education

Master of Science - Biotherapeutics

University College Dublin
12.2022

Bachelor of Science - Biotechnology

INTI International University
12.2021

Skills

  • Research & Clinical Trial Start-Up
  • Regulatory Compliance & Ethics Approvals
  • Site Activation & Start-Up
  • Protocol Development & Study Execution
  • Biotechnology & Drug Discovery
  • Phage Display & Antibody Engineering
  • Protein Purification & Characterization
  • Molecular Biology & Microbiology
  • Data Analysis & Laboratory Techniques
  • Fluorometric & Enzymatic Assays
  • Data Analytics & Scientific Reporting
  • Equipment Maintenance & Compliance

Certification

  • ICH-GCP & Clinical Trials Conduct, 01/01/25, Stanford University
  • Good Manufacturing Practices (GMP) for Pharma, 01/01/25, Udemy
  • HPLC & Quality Control in Pharmaceuticals, 01/01/25, Udemy
  • Pharmacovigilance & Drug Safety, 01/01/25, Udemy

Languages

English
French
Hindi

Timeline

Postgraduate Researcher

University College Dublin
01.2022 - 09.2022

Research Associate Intern

Advanced Agricultural Research (AAR)
01.2021 - 09.2021

Undergraduate Research Assistant

INTI International University
02.2019 - 05.2019

Bachelor of Science - Biotechnology

INTI International University

Master of Science - Biotherapeutics

University College Dublin
Hemakshsi Pokiri