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.
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