Director Assay Development Jobs in Utah (NOW HIRING)

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.
Key Accountabilities/Core Job 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

Qualifications/Skills:

• 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)
• Biologics analytical experience (e.g., CE-SDS, icIEF, potency) is a plus, not required
• Ability to work onsite in Salt Lake City, 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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