Client: Gi Group SA
Location: Not specified
Job Category: Other
Job Reference: ad4c6069108f
Job Views: 5
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description: The world leader in in-vitro diagnostics, Roche Diagnostics in Rotkreuz (ZG), is looking for an open-minded and proactive team player as Scientist Lab Technician Assay Development (m/f/d) .
The Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR technology in the areas of infectious diseases, genomics, and oncology, from early feasibility to commercial launch. Their main areas of responsibility include initial prototyping; optimization of assay design to meet product requirements and ensure manufacturability; development of test methods and acceptance criteria; transfer of reagent manufacturing instructions, test methods, and workflows to Operations; the design and execution of verification and validation activities, including guard-band studies, stability studies, and technical performance verification studies; and documentation of analytical performance for product labeling and regulatory submission packages. Throughout the product development phases, Assay Development interfaces with various departments including Research, Operations, Quality, Regulatory, and Business in order to create and realize what patients need next.
Responsibilities: Performing root cause analysis as part of product care case handling
Working with high throughput lab-analyzer
Routine lab work with infectious samples and leading of own experiments including their analysis
Plan and execute different work packages for the development of molecular diagnostics test
Participation in project meetings and presentation of experimental data
Precise documentation of experiments using electronic lab journals according to GMP Standards
Equipment handling and maintenance
Statistical data analysis using different software and tools (e.g. JMP)
Author official documents (e.g. Design History Files)
Minimum Requirements: Graduate as Biomedical Analyst Scientist (BMA HF) or apprenticeship as Lab Technician (Biology, Medical Diagnostics, Chemistry) or at least Bachelor or Master degree in Life Sciences with practical experience from the lab
Min. 2 years of professional lab experience with data analyses and biostatistics
Very good MS-Office and documentation skills
English fluency written and orally is a must
Open-minded team player
Strong analytical thinking to assess problems and develop solutions
Pro-active mindset and organized working style
Flexible, strategic thinking and self-dependent person
Nice to have: Lab experience from a biotechnical environment with infectious sample handling Biosafety Level 2
Experience in a GMP/GLP environment
Your application: Please apply online. For further information about the position, please contact your Gi consultant, Nicolas Keller, MSc Biochemistry (+41 76 471 68 09; [emailprotected]).
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