Denali Therapeutics Benefits Overview

Leads purification and downstream process characterization, validation, technology transfer, and late-stage bioprocess development for large-molecule therapeutics. Authors protocols, reports, and IND/BLA sections; coordinates internal teams and CDMOs; executes chromatography, filtration, and in-process analytical studies; supports manufacturing, batch record review, PPQ campaigns, viral clearance studies, and cell line and cell culture development.

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.