Associate Director, QC Chemistry

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.

Key Accountabilities/Core Job Responsibilities:

• Lead and develop a 2–5 person QC Chemistry team; set priorities, build schedules, run tier huddles, and ensure coverage/cross-training.

• Hands-on (~50%) lab leader supporting critical testing, troubleshooting, record approvals, and bench mentoring.

• Own analytical method lifecycle (readiness, validation/verification/transfer); author/review protocols, reports, and change control.

• Serve as QC SME for HPLC/UPLC, CE-SDS, icIEF, UV/Vis, and potency; ensure phase-appropriate method performance.

• Ensure GMP/ALCOA+ data integrity & GDP; review/approve ELN/LIMS entries; maintain audit readiness and responses.

• Lead OOT/OOS/deviation investigations, root cause, and CAPAs; verify effectiveness and drive timely closure.

• Act as QC lead for method transfers, coordinating with AD/CMC/Manufacturing; define readiness and execute in QC.

• Oversee instrument lifecycle (URS inputs, IOQ/PQ, calibration/PM, training, release-to-use) with ENG/vendors.

• Drive operations & KPIs (TAT, investigation cycle time, schedule adherence); standardize SOPs/templates, publish dashboards; oversee routine QC chemistry, raw-material release, stability testing, and sample management

• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Qualifications:

• BS in Biology or Chemistry (or related) with 7+ years of GMP QC (biologics preferred)

• 5+ years managing teams

• Method validation/transfer expertise

• Strong documentation

• CDS/ELN/LIMS (e.g., Empower/ /OpenLAB)

• Onsite SLC, UT with occasional off-shift support.

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.

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