Keerthika Madhavan
Krishnagiri
Summary
Biomedical and pharmaceutical science professional with 3+ years of experience in regulated bio/pharmaceutical laboratory environments, supporting HPLC-based analytical testing, stability studies, GMP/GLP compliance, and data review. Holds a Master’s degree in Biomedical Engineering with a strong academic foundation in bio/pharmaceutical chemistry, instrumental analysis, and healthcare systems.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Stability/Quality Management Associate
ThermoFisher Scientific
Mississauga
04.2024 - 10.2025
- Supported GMP-compliant stability and analytical programs for APIs, finished drug products, and controlled substances.
- Performed hands-on support of HPLC-based analytical testing, including sample preparation, mobile phase preparation, sequence execution, and system suitability checks, in accordance with SOPs.
- Reviewed HPLC chromatograms, integration parameters, and calculated results to ensure data accuracy, completeness, and regulatory compliance.
- Prepared, reviewed, and finalized stability study reports, trend analyses, and Certificates of Analysis (CoAs).
- Maintained LIMS, eDMS, Sample Manager, and Test Tracker, ensuring traceability, version control, and audit readiness.
- Applied ALCOA+ principles across data handling, documentation, and reporting.
- Collaborated with analytical chemists, microbiologists, QA, and project managers to resolve data discrepancies and support the timely release of results.
- Supported laboratory safety practices and conducted work efficiently in compliance with GMP/GLP requirements.
Oncology Research Associate
University of Windsor
Windsor
09.2021 - 04.2023
- Supported faculty researchers during symposiums, conference presentations, and workshops by assisting with NCBI/PubMed literature reviews, grant-funded project data, and ongoing research findings.
- Managed procurement of essential research materials, including reagents, primers, buffers, enzymes, and antibodies from biotechnology suppliers.
- Collaborated in a team environment to analyze and interpret data from various techniques such as methylation-specific PCR, qPCR, Western blotting, gel electrophoresis, immunoassays, and ELISA assays.
- Facilitated the informed consent process with hospital staff and patients for the collection and use of bone marrow blood samples in research, ensuring patient confidentiality and ethical compliance.
- Regularly prepared reagents and buffers using acid-base titration and chromatography for experimental use.
- Sub-cultured and processed U2OS and Saos-2 mammalian cell lines, along with human primary cancerous blood samples, adhering to GMP regulations in a BSL-2 laboratory to isolate DNA and proteins.
- Investigated the role of cell cycle regulators, including PLK1, PLK2, PLK3, and PLK4, in the pathogenesis of Multiple Myeloma.
Medical Device Project Research Intern
Glendor, Inc
Utah
01.2021 - 09.2021
- Interviewed doctors and medical officials and used Excel to create PivotTables to communicate key findings, present data and keep track of each meeting.
- Promoted the Artificial Intelligence (AI) based PHI sanitizer medical device/interface to medical officials and scientists using known information.
- Created boxplots to visualize demographic-based data of patient confidentiality in different regions.
- Gathered, arranged, and corrected quantitative research data using Microsoft Power BI based on coverage, accessibility, and eligibility requirements of medical images to create representative graphs, manuscripts, and charts highlighting results for presentations.
Education
M. Eng. - Biomedical Engineering
University of Toronto
Toronto, Canada10.2024
B. Sc (Honors) - Molecular Biology & Biotechnology
University of Windsor
Windsor, Canada04.2023
Skills
- Analytical and hypothesis-driven problem-solving
- Cross-functional collaboration
- Technical documentation and reporting
- LIMS, eDMS, Test Tracker, Sample Manager
- Microsoft Excel (advanced), PowerPoint, Confluence, and Microsoft Project
- PMBOK principles of project management
- AutoCAD, SolidWorks, Power BI, Minitab, R Studio (biostatistical analysis)
- GMP and GLP compliance, ALCOA principles, ICH guidelines
- DNA/RNA extraction, PCR/qPCR, HPLC, Western blotting, ELISA, immunoassays, and gel electrophoresis
Certification
- Good Manufacturing Practices and Good Distribution Practices, ThermoFisher University, 07/01/2024
- Quality Concepts & Principles of Quality Assurance Certificate, Coursera, 04/01/2024
- Applied Clinical Research Certification, McMaster University (Online), 08/01/2023
- Tri-Council Policy Statement Certification, Panel on Research Ethics, 06/01/2023
Projects
IVC filter redesign – regulatory and quality focus
- Redesigned an inferior vena cava filter, integrating pressure microsensors and gold nanoparticles for enhanced clot detection and radiographic visibility
- Developed marketing requirement specifications (MRS), risk assessments, and verification/validation plans
- Applied ISO 13485, ISO 9001, ISO 14971, IEC 60601, IEC 62366, ISO 10993, and ISO 14155 standards
- Conducted patent landscape analysis and regulatory documentation to support product development
Pulse oximeter redesign – human factors engineering
- Conducted hierarchical task analysis, usability studies, and rapid prototyping using SolidWorks
- Performed formative and summative evaluations aligned with ISO 9241 human factors standards
- Analyzed patient and clinician feedback to improve device usability and safety
References
Available upon request
Timeline
Stability/Quality Management Associate
ThermoFisher Scientific
04.2024 - 10.2025
Oncology Research Associate
University of Windsor
09.2021 - 04.2023
Medical Device Project Research Intern
Glendor, Inc
01.2021 - 09.2021
M. Eng. - Biomedical Engineering
University of Toronto
B. Sc (Honors) - Molecular Biology & Biotechnology
University of Windsor