Senior Manager, QC Chemistry

Denali Therapeutics•Salt Lake City, UT

3d•Onsite

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. The Senior Manager, QC Chemistry will serve as both a technical and people leader within the QC Chemistry group, overseeing up to 5 chemists responsible for analytical testing of biologics and related materials. This individual will ensure the delivery of safe, compliant, and on-time analytical results at scale. This is a hands-on leadership role with routine lab work (approximately 40–60%, workload-dependent) required to support critical testing, troubleshooting, and method lifecycle activities. The ideal candidate will play a key role in supporting both clinical and commercial readiness by ensuring phase-appropriate method performance, data integrity, and operational excellence across all testing activities, with a strong emphasis on chromatography-based methods.

Requirements

Typically requires a BS in Chemistry, Biochemistry, or related field and 8+ years of GMP QC experience (pharma/biotech), including 3+ years of people management experience
Strong hands-on chromatography experience (HPLC/UPLC required)
Prior experience leading or mentoring small teams
Experience with analytical method validation, transfer, and troubleshooting
Strong knowledge of GMP, data integrity (ALCOA+), and QC documentation practices
Experience with OOS/OOT investigations, root cause analysis, and CAPAs
Familiarity with CDS/ELN/LIMS systems (e.g., Empower, OpenLab)

Nice To Haves

Biologics analytical experience (e.g., CE-SDS, icIEF, potency) is a plus, not required

Responsibilities

Lead and develop QC Chemistry team; set priorities, build schedules, run tier huddles, and ensure coverage/cross-training
Hands-on (~50%) lab leader supporting chromatography 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 and core analytical techniques (e.g., UV/Vis); support biologics assays (e.g., CE-SDS, icIEF, potency) as needed
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 and oversee routine QC testing, stability, and sample management
Lead direct report(s) through goal setting, development planning, training compliance, and ongoing performance feedback