QC Chemist (Chromatography)

Denali Therapeutics•Salt Lake City, UT

22h

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This role will play a key role in executing and reports analytical/chemistry test methods for raw materials, drug substance and drug product for large molecule clinical and commercial products.

Requirements

BS in Chemistry/ Biology/ Biochemistry or a related scientific discipline with 4+ years of experience in a GMP-regulated chemistry laboratory; large molecule/biologics experience preferred.
Strong knowledge of GMP regulations and current USP/Ph. Eur., FDA, and ISO standards and guidance.
Demonstrated ability to work independently while building productive relationships with internal teams and external partners, with excellent written and verbal communication skills.
Proven track record of right-first-time execution, accuracy, and proactive problem solving, with strong collaboration and project management capabilities
Proficiency with MasterControl and LabWare LIMS is required.
Ability to meet laboratory physical requirements, including specialized gowning, lifting and manipulating items greater than 25 lbs, climbing ladders, and standing for extended periods.

Responsibilities

Implementation and execution of routine and ad hoc analytical testing for raw materials, drug substance, and drug product using chromatography and electrophoretic methods.
Executes and supports chromatography-based assays including SEC, Reverse Phase HPLC (titer), icIEF, and glycan/sialic acid analyses for large molecule programs.
Supports the qualification, transfer, and implementation of USP/EP and product-specific analytical methods, particularly chromatography-based assays, as part of new product introduction and technology transfer.
Performs stability testing of drug substance and drug product across all required timepoints and storage conditions.
Generates, analyzes, interprets, and reports analytical data, ensuring accuracy, data integrity, and appropriate follow-up actions.
Initiates and supports QC-Chemistry investigations and quality events including deviations, CAPA, change controls, and LIR/OOS as a subject matter expert in QC Chemistry.
Works within LabWare LIMS for method execution, data review, trending, and report issuance.
Reviews analytical documentation to support product disposition, including preparation of COA/COC and batch summary reports.
Collaborates cross-functionally with Analytical Development, Manufacturing, and Quality teams during method transfer and assay troubleshooting.
Works with accuracy, urgency, and a continuous improvement mindset and provides flexible support including on-call or outside normal business hours when required.