- Conduct sterility testing for whole blood, RBC, plasma, platelets, cryoprecipitate and granulocytes per IP/BP/USP <71>
- Perform sterility on plasma derivatives, cell therapy products and advanced biologics
- Run bacterial endotoxin testing (Gel-clot, Kinetic Turbidimetric and Chromogenic LAL)
- Execute microbial limit tests, antimicrobial efficacy and preservative challenge studies
- Perform pathogen detection and identification using VITEK, MALDI-TOF and PCR
- Support molecular biology testing — qPCR, GMO screening, species identification, microbial DNA
- Maintain culture collection, media preparation and growth promotion records
- Conduct environmental monitoring of cleanrooms, water systems and personnel
- Investigate microbial OOS, contamination events and prepare CAPA
- Maintain compliance with ISO/IEC 17025 and pharmacopoeial requirements
Qualifications & Experience
- M.Sc. in Microbiology / Industrial Microbiology / Biotechnology
- Experience in sterility testing, BET (LAL), MLT and environmental monitoring
- Knowledge of USP <61>, <62>, <71>, IP and BP microbiology chapters
- Aseptic technique and cleanroom (Grade A/B) handling experience
- Exposure to molecular methods — PCR, qPCR, gel electrophoresis
Core Skills We Look For
Aseptic technique & cleanroom behaviour Sterility testing (membrane filtration & direct inoculation) LAL / endotoxin testing PCR / qPCR & molecular workflows Microbial identification (VITEK / MALDI-TOF)
Nice to Have
- Experience with cell therapy / CAR-T / cord blood sterility
- Hands-on with Next-Generation Sequencing (NGS) workflows
- Internal auditor certification for ISO/IEC 17025
What You'll Learn at YONTUS
- Sterility release testing for advanced biologics and blood components
- Molecular diagnostics across food, pharma and clinical research segments
- Cleanroom qualification and microbial risk assessment
YONTUS Life Sciences is an equal-opportunity employer. We welcome applications from women, persons with disabilities and candidates from underrepresented backgrounds.