Description
We are looking for
Support for the Development and Validation of assays (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Vienna
Branch: Forschung und Entwicklung im Bereich Biotechnologie
Your tasks:
- Perform analytical testing for the development / setup / transfer / (limited) validation of assays required for GMP-release and stability analyses for a project in clinical development
- Writing and reviewing of GMP-relevant documentation (e.g. SOP, FRM, DR)
- Training of internal staff on GMP-methods
Your qualifications
- Background and experience within a virology/immunology/cell biology/molecular biology laboratory, working according to GxP within a recognized quality system
- Experience in qualification and validation of product test methods
- Thorough understanding of current Good Manufacturing Practices (GMP), ICH guidance for quality practices as well as other pharmaceutical regulatory guidelines
- Experience in the biotechnology industry is of advantage
Skills:
- Quality manager
Keywords: Development Transfer Validation assays GMP release stability analyses virology immunology cell biology molecular biology laboratory