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Scientist - Product Development
Il y a 7 mois
We are looking for a **Scientist** in order to reinforce our **Assay development team **(development of IVD assays).
MiDiagnostics is developing technology that can miniaturize all the sample processing steps performed in clinical laboratories and turn it into a disposable, point-of-care form without compromising on performance.
As our Scientist you will be part of this **revolutionary and unique approach, **contributing to product design and development by generating data and knowledge and supporting product transfer, verification and clinical validation to allow the transition from test prototypes to market ready products.
As our Scientist, you will:
- Develop new sample prep methodologies for nucleic acid extraction on solid phase from diverse clinical specimens;
- Design and develop new methods for nucleic acid amplification and detection and optimize on chip diagnostic assays;
- Design and execute functional testing of molecular assay on chip;
- Actively participate to project teams bringing scientific and technical support;
- Actively contribute to product transfer and verification;
- Partake to cross-functional discussions and meetings (e.g. interact with silicon chip designers and process engineers for iterative development of diagnostic modules);
- Timely deliver work packages, data quality, SOPs, protocols, reports and safety documentation according to ISO standards.
- MSc with > 4 years’ experience in IVD industry or PhD degree in molecular biology, biochemistry or related disciplines;
- Experience with molecular detection technologies (PCR, LAMP, NGS) and assay design and development;
- Experience with mammalian, bacterial and viral cultures, sample preparation and nucleic acid extraction;
- Experience in development of IVD products is desirable;
- Fluent in English (written and spoken);
- Ability to design, plan and execute experiment independently including data analysis;
- Excellent analytical thinking and data interpretation;
- Effective written and oral communication in reporting results ;
- A thorough understanding of chemistries related to nucleic acids extraction and solid phases interaction;
- A keen interest in novel technologies for molecular diagnostics;
- Hands-on and resourceful problem solver;
- Attention to detail, works in a structured and methodical way;
- Ability to follow SOP and ISO guidelines and lead product verification and validation;
- Flexibility to work on a variety of projects and switch according to priorities;
- Generation of process quality documentation (quality procedures, work instructions, templates, protocols and reports);
- Excellent team-player;
- Our offices are located in Leuven. Entitlement to live and work in Belgium is required.
