Pavithra Karuppusamy

About Pavithra Karuppusamy

Biotechnology professional with 8+ years of proven expertise in Quality Control (QC), Analytical R&D, and Stability Program Management for biologics, including monoclonal antibodies, therapeutic proteins, and parenteral drug products. Experienced in leading stability studies compliant with global regulatory guidelines primarily targeting Rest of the World (ROW) markets including WHO, EMA, ANVISA, and CDSCO.Core competencies include:Stability Study Design & Execution: Managing end-to-end stability programs covering shelf-life determination, label claim validation, container closure system (CCS) studies, comparative stability, and forced degradation studies in compliance with ICH Q1A(R2) and WHO guidelines.Analytical Techniques & Troubleshooting: Proficient in chromatography, electrophoresis, and spectroscopy. Hands-on experience in method development, method qualification, and analytical troubleshooting.Regulatory Compliance & Documentation: Expert in preparing stability protocols, stability reports, Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA) Risk assessment, MDR, and MQR. Experienced in supporting regulatory submissions and responding to audits.Cross-functional Leadership & Change Control: Leading GxP-compliant change control processes, coordinating with R&D, Manufacturing, QA, and Regulatory Affairs teams to ensure robust product quality and regulatory alignment.Extractables & Leachables (E&L): Working knowledge of E&L studies for parenteral drug products and container closure integrity evaluations.Recognized for delivering high-impact results in cross-functional projects within regulated biopharmaceutical environments focused on ROW markets. Combining deep technical knowledge with strategic leadership to drive biologics product quality, regulatory readiness, and successful global commercialization.Open to senior leadership opportunities in biologics stability, quality control management, and analytical development focused on regulatory compliance and global product lifecycle management.

Experience

1. Specialist Stability

   Amgen

   Mar 2026 — Present · Hyderabad, IN

Education

• Bharathiar University, Coimbatore

  Master's degree, Biotechnology

  2015 — 2017