Senior Manager, QC Microbiology

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, including weekends and off‑shift coverage, ensuring resources, instrumentation readiness, and cross‑training/coverage.
• Own the site’s risk‑based Environmental Monitoring (EM) program for ISO5/7/8 (GradeA–D) areas: sampling plans, alert/action limits, contamination control strategy, and data review.
• Oversee viable/non‑viable, surface, air, and personnel monitoring; review, approve data and deliver routine trend reports.
• Lead EM excursions, OOS/OOT investigations and deviations; perform root‑cause analysis, risk/impact assessments, and drive CAPAs to closure.
• Perform or oversee 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.
• Maintain data integrity and inspection readiness; use LIMS/ELN and EM systems, perform periodic reviews/audit‑trail oversight, and host regulatory and internal audits.
• Maintain compliance with 21
  
  CFR
  211, EU GMP Annex1, and applicable USP/EP/USP chapters; own microbiology/EM metrics, control charts, and dashboards (e.g., TAT, excursion rates, trends).
• Lead direct reports through annual goal setting, growth planning, adherence to company policies, training compliance, and performance feedback.

• Bachelor’s degree required; BS in Microbiology or related field.
• Typically 8+ years of industry experience with 3+ years in management.
• Hands‑on competency in 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:
  
  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; validating/transferring alternative methods (USP//).
• Onsite GMP cleanroom role with routine gowning (GradeB/A as qualified), PPE and aseptic technique.
• Ability to stand for extended periods and lift ~25lbs; weekend/occasional off‑shift work to meet EM and production schedules.

Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. This 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.