QC Chemist

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 supports GMP Quality Control testing for biologic drug substance and drug product, with a primary focus on plate-based potency and impurity assays (e.g., ELISA or similar ligand-binding assays). The QC Chemist will execute routine and stability testing, analyze and report data, and support investigations while maintaining strict compliance with GMP and data integrity expectations.

Key Accountabilities/ Core Job Responsibilities:

Execute plate-based potency and impurity assays (e.g., ELISA or similar ligand-binding assays) in a GMP QC environment supporting biologic drug substance and drug product. Demonstrate hands-on experience with precise manual pipetting, including single- and multi-channel pipettes, for quantitative plate-based assays Perform sample preparation, serial dilutions, reagent preparation, and assay execution with a high level of accuracy and reproducibility. Support qualification, transfer, and routine execution of biologics-specific methods, including potency assays Analyze, trend, and report assay data; identify, document, and escalate atypical or out-of-trend results Support stability testing of biologic drug substance and drug product across all required timepoints and conditions. Serve as a QC Chemistry subject matter contributor for deviations, investigations (LIR/OOS), change controls, and CAPAs related to biologics testing Execute testing and documentation using LabWare LIMS and maintain GMP-compliant, audit-ready records

Required:

prior experience supporting large-molecule / biologics products in a regulated QC laboratory

Qualifications/Skills:

BS in Chemistry or equivalent science 4+ years of experience working in GMP regulated chemistry laboratory Large molecule experience preferred Proven experience performing plate-based potency and/or impurity assays (e.g., ELISA or similar ligand-binding assays with a demonstrated record of precise manual pipetting using single and multi-channel pipettes. Strong understanding of GMP and data integrity requirements for biologics testing, with experience supporting stability testing, assay troubleshooting, and investigations (LIR/OOS, deviations, CAPAs). Proficiency with LabWare LIMS and the ability to execute and document testing in an audit-ready, right-first-time manner. Strong Collaboration and project management skills; ability to partner with internal and external stakeholders. Well-developed verbal and written communication skills Ability to work independently. Physical requirements- must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time. Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.

Learn more at https:

//www.denalitherapeutics.com/careers This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class. Salt Lake City Drug Testing Policy