Quality Control (QC) Analyst

Denali Therapeutics • Salt Lake City, UT

1d

About The Position

The Quality Control (QC) Analyst executes analytical and chemistry test methods for in-process materials, drug substance, and drug product supporting large-molecule clinical and commercial products. The role works under the general supervision of senior QC Chemistry staff and performs routine and ad hoc testing, stability testing, and testing related to analytical method validation, transfer, and implementation. The Analyst generates and reports data in accordance with data-integrity requirements, supports quality investigations and documentation, and collaborates with Analytical Development, Manufacturing, and Quality teams. The role also includes laboratory preparation and upkeep, instrument checks, training, and flexible support with a focus on accuracy, urgency, and continuous improvement.

Requirements

• Typically requires a BS in Chemistry, Biology, Biochemistry, or a related scientific discipline.
• 4+ years of experience in a GMP-regulated laboratory, including hands-on chromatography (HPLC/UPLC) experience.
• Working knowledge of GMP regulations and familiarity with current USP/Ph. Eur., FDA, and ISO standards and guidance.
• Ability to follow established procedures with attention to detail and a right-first-time approach, with developing ability to work independently under general supervision.
• Effective written and verbal communication skills and ability to build productive working relationships with internal teams.
• Experience with LIMS and electronic quality management systems 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.

Nice To Haves

• Large-molecule or biologics experience.
• Experience with LabWare LIMS, MasterControl, and Waters Empower.

Responsibilities

• Execute routine and ad hoc analytical testing of raw materials, drug substance, and drug product using chromatographic and electrophoretic methods under approved methods and procedures.
• Perform chromatography-based assays, including SEC, Reverse Phase HPLC (titer), icIEF, CE-SDS, and glycan/sialic acid analyses for large-molecule programs.
• Participate in validation, transfer, and implementation of USP/EP and product-specific analytical methods by executing protocol testing under senior QC staff direction.
• Perform drug substance and drug product stability testing at required timepoints and storage conditions.
• Generate, process, and report analytical data accurately and in compliance with data-integrity requirements; promptly escalate atypical or unexpected results.
• Support QC-Chemistry investigations and quality events, including deviations, LIR/OOS, CAPA, and change controls, by providing accurate laboratory documentation, data, and observations; initiate LIR/OOS records when required.
• Use LabWare LIMS for sample login, method execution, and result entry.
• Assist with review of analytical documentation for product disposition.
• Help draft risk assessments, protocols, methods, and other QC documentation as needed.
• Collaborate with Analytical Development, Manufacturing, and Quality teams during method validation and transfer and assay troubleshooting.
• Prepare reagents, buffers, mobile phases, and reference standard solutions.
• Perform routine instrument checks, preventive maintenance, and calibration verification; maintain laboratory supplies and sample inventory.
• Complete required training and keep training records current in accordance with site procedures.
• Provide flexible support while working accurately, urgently, and with a continuous improvement mindset.

Benefits

• Competitive total rewards package, including a 401k, healthcare coverage, ESPP, and a broad range of other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level