Scientist Lab Technician Assay Development (m/f/d)

Scientist Lab Technician Assay Development

(m/f/d)

Freelance/temporary employment for a project Zug Start date: asap Reference number: 873185/1

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Project information

• 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. The 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

• Working with high throughput lab – analyzer
• Routine lab work with infectious samples and leading of own experiments including the analysis of them
• 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 ( JMP)
• Author official documents ( Design History Files)

Profile

• 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 (no PhD graduates)
• Lab experience with data analyses and biostatistics
• Very good and thorough documentation skills
• English fluency written and orally is necessary, German is advantageous
• Open-minded team player
• Pro-active mindset and organized working style
• Strategic thinking and self-dependent person
• Lab experience from a biotechnical environment with infectious sample handling Biosafety Level 2
• Experience in a GMP/GLP environment

Benefits

• Future career opportunities
• World renowned pharmaceutical company