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




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. Our 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 (e.g. JMP)
- Author official documents (e.g. 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 a must, German is a plus
- Open-minded team player
- Pro-active mindset and organized working style
- Flexible, 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
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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