Jobs at Denali Therapeutics

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.

Lead downstream purification technical activities for commercial and late-stage biologics: support commercial manufacturing, tech transfers, process characterization, investigations, change management, regulatory filings, and lifecycle improvements while aligning cross-site and CDMO operations.

Lead commercial analytical lifecycle activities for a launched biologic, providing CMO and QC technical support, overseeing method transfers and validation, responding to global health authority questions, and partnering cross-functionally to ensure uninterrupted commercial supply and harmonized testing across sites.

Lead bioassay development for protein biologics across the lifecycle, providing technical and people leadership to develop, qualify, validate, transfer, and lifecycle-manage potency and plate-based impurity assays. Establish assay control strategies, partner cross-functionally and with external labs, support regulatory filings and GMP readiness, mentor scientists, and drive phase-appropriate assay strategies that enable clinical development and commercial readiness.

Lead and validate downstream purification processes for large-molecule therapeutics, design and execute lab-scale chromatography and filtration studies, author IND/BLA sections, coordinate CDMO/CMO transfers and PPQ activities, analyze in-process and analytical data (ELISA, HPLC, LC-MS, SDS-PAGE), and support late-stage manufacturing and viral clearance studies.