Senior Manager, QC Microbiology

Overview

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.

Lead the QC Microbiology function for our GMP site providing environmental monitoring (EM) and microbiology services in support of biologics programs (drug substance and drug product). This role is both hands-on (up to ~50% at the bench) and managerial, responsible for people development, inspection-ready execution, and data-driven trending. You will own the site EM program (viable & non-viable) and compendial microbiology testing (e.g., bioburden, endotoxin, sterility, microbial identification) with a preference for biologics/aseptic operations experience.

Weekend flexibility and occasional off-shift coverage are required to support EM and production schedules.

• Lead, mentor, and develop a 3–5 person QC Microbiology team; foster a strong safety, GMP (ALCOA+) and continuous-improvement culture.
• Plan capacity and schedules (incl. weekends/off-shift); ensure resources, instrumentation readiness, and cross-training/coverage.
• Own the site’s risk-based Environmental Monitoring (EM) program for ISO 5/7/8 (Grade A–D) areas, including sampling plans, alert/action limits, and contamination control strategy.
• Oversee viable/non-viable, surface, air, and personnel monitoring; review/approve data and deliver routine trend reports.
• Lead EM excursions and other investigations (OOS/OOT/deviations); perform root-cause and risk/impact assessments; drive CAPAs and effectiveness checks to closure.
• Oversee and as needed, perform compendial testing (bioburden, endotoxin/LAL, sterility, microbial /confirmation, growth promotion) and utilities monitoring (water/gases).
• Author/review SOPs, protocols, and reports; lead method suitability/verification/transfer and manage change controls.
• Partner with Manufacturing/MSAT/QA/Engineering on aseptic practices, cleaning/disinfection programs, and overall contamination control.
• Ensure data integrity and inspection readiness; utilize LIMS/ELN and EM systems, perform periodic reviews/audit-trail oversight; host regulatory and internal audits.
• Maintain compliance with 21 CFR 211, EU GMP Annex 1, and applicable USP/EP/USP chapters; own microbiology/EM metrics, control charts, and dashboards (e.g., TAT, excursion rates, trends)
• Lead direct reports(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

• Bachelors required; BS in Microbiology (or related)
• Typically 8+ years of industry experience and 3+ years of management experience
• Hands-on competency across EM and core microbiology assays with ~50% lab/cleanroom presence
• Proven ownership of site EM programs and compendial testing
• Strong GMP documentation/technical writing, LIMS fluency, and basic statistical trending
• Demonstrated ability to coordinate schedules/workflows, mentor/train others, and support weekend/off-shift coverage
• Excellent communication, collaboration, and problem-solving skills.

• Fill-finish or cell-culture/DS and contamination-control strategy
• JMP (or equivalent) for SPC/control-charting and dashboards
• Rapid microbiological methods, disinfectant-efficacy studies, utilities monitoring (WFI/PW/clean steam/compressed gases)
• Hosting inspections/overseeing CMOs or contract labs, and validating/transferring alternative methods (USP)
• Onsite GMP cleanroom role with routine gowning (Grade B/A as qualified), PPE and aseptic technique
• Ability to stand for extended periods and lift…