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.
Key Accountabilities/Core Job 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
Qualifications/Skills :
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 experience includes:
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 <1223>/<1225>/<1227>)
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
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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