Michelle J Chinnadurai

About Michelle J Chinnadurai

I am a graduate student majoring in Regulatory Affairs for Biopharmaceuticals at Northeastern University. My educational background in biotechnology and my work experience in Quality Control and MSAT for biological drug products have helped me develop a deep understanding of the significance of quality in regulated biological products and how quality is ensured in the development, manufacturing, and testing stages. Over the years, I have gained expertise in analytical techniques such as CE, UPLC, particle size analysis, and USP compendial methods for biologics, along with the ability to troubleshoot technical issues. Additionally, I have worked closely with analytical method validation and qualification for parameters such as linearity, precision, robustness, specificity, and system suitability, and developed a deep understanding of the ICH Q2(R2) guideline. The GMP environment has also exposed me to collaborate with cross-functional teams such as quality assurance, manufacturing, and R&D for quality events such as CAPAs, deviations, laboratory incidents, and out-of-specifications.While my hands-on experience in a GMP facility has sharpened my analytical skills and improved my attention to detail, the corporate environment has taught me to accomplish deadline-driven tasks through effective communication, time management, and collaboration both within teams and cross-functional teams.Graduate school has been helping me navigate the regulatory landscape from a clinical, safety, and quality perspective, offering insights into regulatory pathways, ICH guidelines, and regulations that govern biopharmaceutical drug development. It also teaches me the application of these concepts through case studies and paper submissions. The sum of my educational background and work experiences have driven me to pursue a career in CMC development of biopharmaceuticals. I\'m excited to dive into roles focused on analytical method development, quality control, method validation, quality assurance, compliance, and CMC regulatory affairs. Outside of work, I enjoy reading books, writing poetry, watercolor painting, and baking cakes.

Experience

1. Senior Research Associate

   Asimov

   Oct 2025 — Present · Boston, MA, US

Education

• Northeastern University

  Master of Science - MS

  2023 — 2025

• Karunya Institute of Technology and Sciences

  Bachelor of Technology

  2013 — 2017