Summary
Overview
Work History
Education
Skills
Certification
Awards
Timeline
Generic

POORNA CHANDRA

Pearland

Summary

Experienced Pharmaceutical Professional with basic expertise in Cell & Gene Therapy, AAV-LNP, and Bioanalysis

Overview

9
9
years of professional experience
1
1
Certification

Work History

Quality Control Analyst III, Cell Therapy

Lonza Biologics, INC
09.2023 - Current
  • Perform and analyze complex cell-based assays such as flow cytometry (BD FACS Lyrics), ELISA, and IFN-Gamma potency assays to ensure product quality.
  • Monitor cell therapy manufacturing processes by summarizing and analyzing data, including flow cytometry (BD FACS Lyrics) and complex cell-based assays.
  • Assess major deviations impacting product quality, identify root causes using systematic approaches, and propose corrective actions.
  • Troubleshoot material-related failures in cell therapy processes, facilitate discussions with vendors and customers to identify compliance modifications.
  • Support Cell Therapy technology transfer activities and validation of analytical methods, including training on new methodologies, setup of new equipment, generation of SOPs, and execution of validation protocols.
  • Write and revise SOPs, Forms, and Test Records. Author, edit, and approve Deviations and CAPAs as required. Initiate Change Controls and complete necessary documentation.

Graduate Student Researcher

The State University of New York at Buffalo
08.2021 - 08.2023
  • Preparation and Optimization of Novel Lipid Nanoparticles with AAV-serotype 8
  • Biophysical Characterization of Lipid Nanoparticles with AAV serotype 8 using HPLC-SEC
  • Stability analysis of Novel Lipid Nanoparticles with AAV8 by using Fluorescence Anisotropy
  • Understanding the Morphology of AAV8 with Lipid Nanoparticles by Transmission Electron Microscopy (TEM)
  • Determining the Size distribution of AAV with LNPs using the differential Light Scattering technique
  • Characterization and quantification of AAV with LNP by Density gradient Ultracentrifugation and Sandwich ELISA
  • I kept record of daily experiments in written and electronic format and regularly presented results in lab meetings.

Regulatory Scientific Analyst, Clin. Pharmacology

Clarivate
04.2019 - 08.2021
  • Reviewing and approving protocols, Standard Operating Procedures (SOPs), and study-related documents to ensure compliance with quality standards
  • Monitoring and evaluating the performance of clinical pharmacology studies, including data collection, management, and reporting to ensure accuracy, completeness, and consistency
  • Extraction of Preclinical, Clinical Pharmacokinetic, and Pharmacodynamic and process them in the Cortellis Drug Discovery Intelligence database system
  • Supporting the identification, (CAPA) investigation, and resolution of quality issues, deviations, and non-conformances related to Clinical Pharmacology data
  • Understanding Regulatory requirements such as 21 CFR part 11, ICH E6 GCP, and 21 CFR part 820
  • Assisting in the development and execution of risk assessment and risk mitigation strategies for clinical trials, including the identification of critical quality attributes and risk factors
  • Collaborating with cross-functional teams, including clinical operations, data management, biostatistics, and medical writing to ensure effective communication and resolution of quality-related matters.

Research Associate 2, Bioanalysis

Aragen Life Sciences
04.2018 - 03.2019
  • Understanding in handling LC-MS/MS From Sciex under the supervision of Senior Scientists
  • Performing and Analyzing sample preparations and cell-based assays, NAb Assays to support ADME
  • Performed Anti-Drug antibody assay method by bridging ELISA with anti-bevacizumab antibody using bevacizumab antibody
  • Prepared and analyzed different LC-MS samples (including biological samples) according to SOPs
  • Maintained Good Laboratory Practice and documentation
  • Prepared and Reviewed work protocols, SOPs, and procedures under the guidance of Senior Scientists
  • Maintain and Update Internal departmental procedures in accordance with ICH and global regulatory guidelines.

Graduate Student Assistant

Jawaharlal Nehru Technological University-Center for Translational Sciences
09.2015 - 01.2018
  • Performed Acute oral toxicity study and established the experimental dose to be administered
  • Observed changes in body weight, tumor volume, viable and non-viable tumor cell count, mean survival time, and percentage of increase in life span to compare the anti-tumor potential of the test with a suitable standard
  • Conducted the cytotoxic effect of the test compound on various cancer cell lines by XTT assay
  • Conducted apoptosis in cancer cell lines by DNA Laddering assay
  • Evaluating the Dose response of MEOS and Tamoxifen on EAC cells, MCF-7 cells, and MDA-MB 435S
  • Evaluating the effect of MEOS on Non-viable tumor cell count, Hemoglobin, and %Increase in Lifespan of mice bearing EAC.

Quality Assurance/Bioanalytical Intern

Aurigene Drug Discovery Technologies
06.2017 - 11.2017
  • Under Minimal supervision, established and maintained an organized document control system that includes creating and managing document repositories, version control, and document retention
  • Worked closely with SMEs to create and review GMP-related documents such as SOPs, batch records, protocols, and reports
  • Played an active role in maintaining the quality of documentation and implementing CAPA as needed
  • Assisted in regulatory inspections and Internal/External audits related to document control and ensuring compliance with GMP regulations and industry standards
  • Actively participated in process improvement initiatives related to document control
  • This includes identifying areas for efficiency gains and proposing system enhancements and implementing best practices to streamline document control operations.

Education

Masters in Pharmaceutical Sciences (Thesis Track) -

The State University of New York At Buffalo
New York, New York
08.2023

Master of Science - Pharmacology And Toxicology (Thesis Track)

Jawaharlal Nehru Technological University, Center For Translational Sciences
04.2018

Skills

  • Flow Cytometry
  • Cell Culture
  • ELISA
  • Protein Characterization (AAV-LNP)
  • Circular Dichroism
  • Fluorescence Anisotropy
  • Manual & Automated Cell counts
  • Cell based assays
  • HPLC-Size Exclusion Chromatography
  • Tangential Flow Filtration
  • Graphpad Prism
  • Image J
  • Statistical Data Analysis
  • cGMP Regulations

Certification

  • IELTS-7.5
  • Certified Registered Pharmacist from the Pharmacy Council of India(PCI)
  • Qualified Pharmacy College Admission Test (PCAT-2021)

Awards

  • Qualified Graduate Pharmacy Aptitude Test (GPAT) All India Rank-911 in 2015.
  • Qualified Indian Council of Medical Research-Junior Research Fellowship-2016
  • Qualified Post-Graduate Common Entrance Exam with 101 rank-2015
  • Participated in an International Seminar competition held at the CENTREFOR CELLULARAND MOLECULAR BIOLOGY and won a silver medal.
  • Industrial Visits to Dr Reddy's Laboratories, Nektar Therapeutics, and Indian Immunologicals Ltd
  • Attended Pharmacometrics workshop on PHOENIX WINONLIN-THE SWISSARMY KNIFE in PK/PD by J.Bulitta, Ph.D. University of Florida

Timeline

Quality Control Analyst III, Cell Therapy

Lonza Biologics, INC
09.2023 - Current

Graduate Student Researcher

The State University of New York at Buffalo
08.2021 - 08.2023

Regulatory Scientific Analyst, Clin. Pharmacology

Clarivate
04.2019 - 08.2021

Research Associate 2, Bioanalysis

Aragen Life Sciences
04.2018 - 03.2019

Quality Assurance/Bioanalytical Intern

Aurigene Drug Discovery Technologies
06.2017 - 11.2017

Graduate Student Assistant

Jawaharlal Nehru Technological University-Center for Translational Sciences
09.2015 - 01.2018

Masters in Pharmaceutical Sciences (Thesis Track) -

The State University of New York At Buffalo

Master of Science - Pharmacology And Toxicology (Thesis Track)

Jawaharlal Nehru Technological University, Center For Translational Sciences

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