Senior Manager, QC Microbiology

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 hands-on (~50% at the bench) and managerial, responsible for people development, inspection-ready execution, and data-driven trending. Own the site EM program (viable & non-viable) and compendial microbiology testing (bioburden, endotoxin, sterility, microbial identification). Weekend flexibility and occasional off-shift coverage required.

Key Accountabilities/Core Job Responsibilities
- Lead, mentor, and develop a 3–5 person QC Microbiology team; foster safety, GMP (ALCOA+), and continuous improvement culture.
- Plan capacity/schedules (weekends/off-shift), ensure resources and instrumentation readiness, and cross-train/coverage.
- Own risk-based EM program for ISO 5/7/8 (Grade A–D) areas (sampling plans, alert/action limits, contamination control strategy).
- Oversee viable/non-viable, surface/air/personnel monitoring; review/approve data and deliver routine trend reports.
- Lead EM excursions and investigations (OOS/OOT/deviations); perform root-cause/risk assessments; drive CAPAs to closure.
- Oversee/perform compendial testing 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 and contamination control.
- Ensure data integrity and inspection readiness; utilize LIMS/ELN/EM systems; host regulatory/internal audits.
- Maintain compliance with 21 CFR 211, EU GMP Annex 1, and applicable USP/EP chapters; own microbiology/EM metrics and dashboards.

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

Preferred Experience Includes
- Fill-finish or cell-culture/DS; contamination-control strategy.
- JMP (or equivalent) for SPC/control charts/dashboards.
- Rapid microbiological methods, disinfectant-efficacy studies, utilities monitoring (WFI/PW/clean steam/compressed gases).
- Hosting inspections/overseeing CMOs or contract labs; validating/transferring alternative methods.
- Onsite GMP cleanroom experience with gowning (Grade B/A as qualified), PPE, aseptic technique.
- Ability to stand extended periods and lift ~25 lbs; weekend/occasional off-shift work.

Benefits/Application
- Denali offers a competitive total rewards package (401k, healthcare coverage, ESPP, and other benefits). Learn more at https://www.denalitherapeutics.com/careers