Teams at Denali Therapeutics

Leads quality operations for Denali’s Utah clinical and commercial manufacturing site, overseeing QA, QC, GMP/GLP compliance, batch release, inspection readiness, quality systems, audits, CAPAs, validations, and quality metrics. Builds and develops QA/QC teams, represents Quality on leadership teams, supports site qualification and health authority interactions, and partners on long-term site strategy and continuous improvement.

Perform and develop chromatography, electrophoresis, spectroscopy, and mass spectrometry methods for release, stability, and characterization of biologics. Design and execute experiments to demonstrate method robustness, analyze data to support development decisions, and prioritize testing to meet project timelines. Maintain ELN records, author methods and reports, and present results to cross-functional teams.

Lead and manage CMC strategies, timelines, budgets, and vendor relationships across drug development stages. Oversee CRO/CMO selection and outsourced manufacturing, drive cross-functional CMC teams, identify risks and mitigations, and report status and forecasts to senior management to ensure timely regulatory submissions and commercialization readiness.