Jobs at Denali Therapeutics

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 mass spectrometry-based large molecule CMC characterization, including primary sequence, PTM, and higher-order structure analysis. Develop phase-appropriate characterization strategies, perform hands-on LC-MS experiments to support comparability/CQA assessments, author regulatory documentation, oversee method transfer/qualification at QC labs, and support late-phase analytical development and control strategy for protein therapeutics.

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.

Manage day-to-day global logistics and supply chain execution for clinical and commercial product. Coordinate shipment booking, tracking, vendor relationships, issue resolution, labeling/packaging, contract coordination, inventory and IRT transactions. Support QP certification tracking, GMP-compliant distribution, and contribute to process definition and continuous improvement across cross-functional teams.

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.