Senior Manager, QC Chemistry
Denali Therapeutics
June 30, 2026
On-site
Salt Lake City, UT
Operations
Key Accountabilities / Core Job Responsibilities:
- Lead and develop the QC Chemistry team (up to 5 chemists); set priorities, build schedules, run tier huddles, ensure coverage and cross-training.
- Hands-on (~40–50%) lab leadership for 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 and GDP; review/approve ELN/LIMS entries; maintain audit readiness.
- Lead OOT/OOS/deviation investigations, root cause, and CAPAs; verify effectiveness and drive timely closure.
- Act as QC lead for method transfers with AD/CMC/Manufacturing; define readiness and execute in QC.
- Oversee instrument lifecycle (URS, IOQ/PQ, calibration/PM, training, release-to-use) with Engineering/vendors.
- Drive operations & KPIs (TAT, investigation cycle time, schedule adherence); standardize SOPs/templates; oversee routine QC testing, stability, and sample management.
Qualifications / Skills:
- BS in Chemistry/Biochemistry or related field; 8+ years GMP QC experience (pharma/biotech); 3+ years people management.
- Strong hands-on chromatography experience (HPLC/UPLC required).
- Experience validating, transferring, and troubleshooting analytical methods.
- Strong GMP and data integrity knowledge (ALCOA+); QC documentation practices.
- OOS/OOT investigation, root cause analysis, and CAPAs experience.
- Familiarity with CDS/ELN/LIMS (e.g., Empower, OpenLab).
- Biologics analytical experience (CE-SDS, icIEF, potency) is a plus.
- Ability to work onsite in Salt Lake City, UT with occasional off-shift support.
Benefits:
- Competitive total rewards package including 401(k), healthcare coverage, and ESPP (plus other benefits).
Application Instructions:
- Learn more at https://www.denalitherapeutics.com/careers
- Lead and develop the QC Chemistry team (up to 5 chemists); set priorities, build schedules, run tier huddles, ensure coverage and cross-training.
- Hands-on (~40–50%) lab leadership for 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 and GDP; review/approve ELN/LIMS entries; maintain audit readiness.
- Lead OOT/OOS/deviation investigations, root cause, and CAPAs; verify effectiveness and drive timely closure.
- Act as QC lead for method transfers with AD/CMC/Manufacturing; define readiness and execute in QC.
- Oversee instrument lifecycle (URS, IOQ/PQ, calibration/PM, training, release-to-use) with Engineering/vendors.
- Drive operations & KPIs (TAT, investigation cycle time, schedule adherence); standardize SOPs/templates; oversee routine QC testing, stability, and sample management.
Qualifications / Skills:
- BS in Chemistry/Biochemistry or related field; 8+ years GMP QC experience (pharma/biotech); 3+ years people management.
- Strong hands-on chromatography experience (HPLC/UPLC required).
- Experience validating, transferring, and troubleshooting analytical methods.
- Strong GMP and data integrity knowledge (ALCOA+); QC documentation practices.
- OOS/OOT investigation, root cause analysis, and CAPAs experience.
- Familiarity with CDS/ELN/LIMS (e.g., Empower, OpenLab).
- Biologics analytical experience (CE-SDS, icIEF, potency) is a plus.
- Ability to work onsite in Salt Lake City, UT with occasional off-shift support.
Benefits:
- Competitive total rewards package including 401(k), healthcare coverage, and ESPP (plus other benefits).
Application Instructions:
- Learn more at https://www.denalitherapeutics.com/careers