Leading bioanalytical innovation, immunogenicity science, and regulatory diagnostics across pharma, CEPI, and FDA
Served as Principal Investigator and Strategic Lead for immunogenicity, pharmacokinetic (PK), translational biomarker, receptor occupancy (RO), and target engagement (TE) method development and validation — supporting both preclinical and clinical programs across multiple therapeutic areas.
Expertise spans ligand-binding, LC–MS/MS, and cell-based assay platforms, enabling regulatory-compliant bioanalytical support from discovery through submission.
Served as Principal Investigator for immunogenicity and safety assessment of global vaccine programs, supporting assay development, qualification, and validation to ensure data integrity and regulatory compliance across clinical phases.
Experience spans immunogenicity assay design, neutralizing antibody assessment, and safety monitoring aligned with WHO, FDA, and EMA vaccine standards.
Served as a Subject Matter Expert at the Coalition for Epidemic Preparedness Innovations (CEPI). Contributed to the evaluation of global vaccine development proposals and helped establish the CEPI Global Laboratory Network spanning 13 countries, to harmonize vaccine testing, quality control, and data standards worldwide.
Advancing global readiness through coordinated, standardized vaccine analytics and collaborative science.
Served as a Scientific and Technical Reviewer in the In-Vitro Diagnostics (IVD) Program at the U.S. Food and Drug Administration (FDA). Evaluated and authorized COVID-19 diagnostic tests under Emergency Use Authorization (EUA), including rapid, point-of-care, and at-home assays, ensuring accuracy, reliability, and regulatory compliance during a global health emergency.
Contributed to accelerating access to high-quality diagnostic tools when rapid, science-based decisions mattered most.
