Teams at Aurion Biotech, Inc.

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.

Lead development, optimization, qualification, and GMP-compliant transfer of analytical methods (flow cytometry, dPCR/qPCR, ELISA, cell-based potency, automated cell counting) to support clinical-stage cell therapy manufacturing. Author qualification and test method SOPs, collaborate cross-functionally, train staff, track project milestones, and ensure regulatory-compliant documentation for US/EU submissions.

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.