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/Vacatures/Senior Assay Developer (Consultant)

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

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