Teams at Aurion Biotech, Inc.

Develop, optimize, qualify, and transfer GMP-compliant analytical methods for cell therapy products (flow cytometry, dPCR/qPCR, ELISA, potency assays). Perform independent lab experiments, author qualification and SOP documentation, collaborate cross-functionally with manufacturing and quality, track project milestones, and support regulatory submission activities for late-stage clinical manufacturing.

Lead method transfers and validations at external CDMOs for cell therapy QC; author/review protocols and reports; troubleshoot assays; establish assay controls and monitor assay validity; ensure cGMP and regulatory compliance; support late-stage clinical development and interface with internal and external stakeholders.