Jobs at Denali Therapeutics

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.

Lead and manage a 3-5 person QC Microbiology team for a GMP biologics site. Own environmental monitoring (viable/non-viable) and compendial microbiology testing (bioburden, endotoxin/LAL, sterility, microbial ID), drive investigations/CAPAs, ensure data integrity and inspection readiness, author/review SOPs, manage LIMS/ELN and trending, support weekend/off-shift schedules and ~50% hands-on lab/cleanroom work.

Support GMP manufacturing at Denali's Salt Lake City site by authoring recipes and SOPs, enabling tech transfers, providing on‑floor process support, monitoring and analyzing process data, leading investigations and validations, coordinating sampling and chain-of-custody to QC, and performing lab-scale cell culture and purification operations.

Lead forecasting, demand and supply planning, and inventory strategy for clinical GMP materials. Serve as supply chain lead for clinical programs, develop IRT and scenario plans, coordinate cross-functionally (CMC, Manufacturing, QA, Regulatory, Clinical Ops, Finance), communicate program status, troubleshoot risks, and drive continuous operational improvements.

Lead development and continuous improvement of the Salt Lake City site operating model, governance, and performance management. Align cross-functional teams (manufacturing, quality, supply chain, MSAT), drive manufacturing readiness and strategic initiatives, establish metrics and reporting, manage resource prioritization, mitigate operational risks, and coach project leadership to enable scalable, inspection-ready operations for late-stage and commercial programs.