Denali Therapeutics Benefits Overview

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.