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Senior Assay Developer (Consultant)
Research & development - Leuven | Just now
We are looking for a (senior) Assay Developer with a strong technical background in development of IVD assays, for the development of a radically innovative testing solution for airborne infectious diseases, such as SARS-CoV-2. Experience with PCR technology and a hands-on track record in assay development up to product development are required. Your experience includes molecular biology methods, protein characterization and purification techniques, GLP and design controlled development. Also see: https://www.imec-int.com/en/expertise/life-sciences/coronavirus-breathalyzer
Senior Assay Developer
The assignment
- Develop state of the art IVD assay and verify its performance in compliance with ISO requirements.
- Interact with technical specialists on all components of the system.
- Interface with external vendors for selection and qualification of components and/or procurement of customized parts.
- Work according to GLP practices. The experience with generation of Product Design History File and Design Change Procedure is a plus.
- Monitor the interdependencies between components; continually assess critical specs; proactively anticipate risks and bottlenecks.
- Work with technical owners to review project contributions and risks and formulate recommendations for customers and management.
- Manage time effectively according to aggressive project schedules.
- Quickly adapt to new project requirements and effectively manage change requests.
Required knowledge and skills
- You have experience in people and project coordination in a high-tech environment.
- At least 5 years of relevant experience in leading medical systems design or IVD product development.
- You are knowledgeable in PCR or immuno technology and applications.
- Have experience in a prototyping and problem solving in product development environment with an interdisciplinary team.
- A team player with excellent communication skills and fluent in English.
- Availability to come and work at the Imec facilities in Leuven is required.
Duration of the assignment
minimum 6 months
Desired start date and work regime
asap - fulltime
Location
imec Leuven