Denali Therapeutics · 6 hours ago
Senior Manager, QC Microbiology
Salt Lake City, UT
Contract
Onsite
Senior Level, Lead/Staff
8+ years expDenali Therapeutics is a biotechnology company focused on developing therapies for neurodegenerative diseases. They are seeking a Senior Manager for QC Microbiology to lead the microbiology function at their GMP site, responsible for environmental monitoring and microbiology services in support of biologics programs.
BiotechnologyGeneticsHealth DiagnosticsTherapeutics
Responsibilities
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 ID/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
Qualification
Required
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
Preferred
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 ~25 lbs; weekend/occasional off-shift work to meet EM and production schedules
Benefits
401k
Healthcare coverage
ESPP
A broad range of other benefits
Company
Denali Therapeutics
Denali Therapeutics is dedicated to defeating neurodegenerative diseases to deliver safe and effective medicines to patients and families.
501-1000 employees
H1B Sponsorship
Denali Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (6)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.32BKey Investors
Royalty PharmaBaillie Gifford
2025-12-04Post Ipo Debt· $200M
2024-02-27Post Ipo Equity· $500M
2022-10-19Post Ipo Equity· $275M
Leadership Team
Ryan Watts
CEO
Peter Chin
Sr. Vice President & Head of Late-Stage Clinical Development and Medical Affairs
Recent News
2026-01-11
Longevity.Technology
2026-01-03
Company data provided by crunchbase