Microbiology Expert – Pyrogen Testing (5269)
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Microbiology Expert /Technician – BET and IPC testing – 5269
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking a Microbiology Expert in BET and IPC testing for a 12-month contract in Basel area, Switzerland.
As a Microbiology Expert you will be supporting the Microbiology Testing team with pyrogen testing: Bacterial Endotoxins Test (BET), Low Endotoxin Recovery (LER) studies, Monocyte Activation Test (MAT).
• Support project teams in BET release, stability and IPC testing incl. AS, JS, VS, AM and analytical batch record reviews reviews
• Support in setting of BET specifications for drug substance, drug product and vehicles
• Review BET method suitability test protocols and report including corresponding analytical raw data
• Support method transfer and reviews transfer protocols and reports (internal and external)
• Write/review risk assessments in case of endotoxin contaminations or deviations
• Support project teams in LER related topics
• Provide expertise for beta-glucan testing analytics
• Review SOPs/WPs
• Support answers to health authority requests (BET and MAT related HA requests)
• Build strong collaboration and standards with external testing laboratories
Qualifications and Experience:
• Relevant working/residency permit or Swiss/EU-Citizenship required;
• PhD, diploma, bachelor or master in microbiology / biotechnology (or related science)
• 1 – 3 years experience within pharmaceutical industry / GMP environment
• Fluent English
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