Backed by 500 Global.
About the role
The Supervisor, QC Microbiology leads a team of microbiology analysts to execute GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing. This role ensures cGMP compliance, data integrity, safety, and right first-time performance, while driving method robustness, investigation quality, and continuous improvement.
What they're looking for
- Environmental monitoring in ISO/Classified spaces and utilities testing
- Sterility testing (e.g., USP ), endotoxin/LAL (USP ), bioburden/microbial limits (USP / ), growth promotion, microbial ID (e.g., MALDI TOF), AET/MVT, and data trending
- Deviation/OOS/OOT investigations, root cause analysis, and CAPA management
- Familiarity with LIMS/ELN, TrackWise or similar eQMS, proficiency with MS Office/Teams
- cGMP, data integrity (ALCOA+), ICH Q7/Q9/Q10, USP/EP/JP, and EU Annex 1 (2022)
- Strong leadership, prioritization, communication, and cross functional collaboration
More about this role
The Supervisor, QC Microbiology leads a team of microbiology analysts to execute GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing. This role ensures cGMP compliance, data integrity, safety, and right first-time performance, while driving method robustness, investigation quality, and continuous improvement. The Supervisor typically supervises staff and junior scientists, manages day-to-day operations, and contributes to cross functional initiatives of moderate complexity.
Shift: Wednesday – Saturday (7am – 5pm)
At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.
From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.
Situated at...
Browse similar: Startup jobs · Remote jobs