Jobs in life sciences

Senior Assay Developer

Ref. 190-SAD
Function: The assay developer will lead the development of a key assay that will be brought to market.
Location: Zwijnaarde

The company:

The company is developing a home testing platform. This specific technology makes it possible to detect protein markers at a consumer price-tag with the ease-of-use of a pregnancy test and with clinical lab performance. The system comprises of a small read-out device and disposable tests. The tests rely on antibody-antigen reactions on silicon photonics technology, combined with microfluidics. The technology has architectural similarities to lateral flow immunoassays.The core proposition is home diagnostics, home monitoring and self-testing by consumers, patients and generally untrained users. 

Job description:

This start-up is developing a “menu” for the self-testing market, with the two first products in the realm of infectious diseases. One focusses on the detection of chlamydia and ghonorrea, while the other on the detection of Influenza virus plus Sars-Cov-2. The senior assay developer will lead the development of one of these key assays which will be brought to market. Both products are developed according to IVD and FDA design control methodologies. Hence, the senior assay developer is responsible for the planning and documentation, according to both regulatory standards.  

The senior assay developer will work closely and report to the assay lead in order to develop the product from early stage to market entry. He/She will be responsible for leading the specific assay team, co-planning the experiments, analyzing the data, initiating & providing follow-up of sub-tasks and reporting to stakeholders. 

Responsibilities: 

  • Planning and execution of experiments in the framework of assay development projects with a focus on the FDA and CE-IVD development.
  • Lead the assay development of one of the infectious diseases products on the Antelope Dx platform, from early R&D phase to clinical validation.
  • Work out the assay architecture including sample collection and sample treatment steps, if any.
  • Co-develop a protein conjugation strategies.
  • Understand the biological and clinical aspects of the assay to the degree that this knowhow can be used in development and to overcome challenges.
  • Data analysis, data interpretation and reporting in the form of documents (closing reports, data summaries, etc.) and oral presentations (status updates, lessons learned, etc.).
  • Lead a small team of 2-4 reseach associates.
  • Define profiles to strengthen the product team and support the hiring of these. 
  • Define experimental targets and plan accordingly.
  • Organizational management activities such as stock inventory, ordering, assigning tasks and responsibilities.
  • Project management activities such as prioritization, time and resource scheduling.
  • Literature research and gathering of relevant scientific information .
  • Identify problems, communicate to the team and develop solutions.
  • Interface with the software team to develop and set clinical outcome algorithms, potentially on multi-analyte detection.
  • Source the necessary clinical and analytical samples required for assay development, product verification and performance validation.
  • Gathering clinical data at the site of clinical partners.
  • Provide ad hoc and cross-disciplinary technical and scientific expertise on assay development.
  • Detect and address emerging issues when they arise.
  • Design experiments and test plans to verify and validate product requirements.
  • Write scientific reports and documentation according to IVD quality standards (ISO 13485).
  • Contribute to continuous improvement of assay execution and development processes.
  • Build up and share scientific and technical expertise by following up on scientific developments and new techniques related to assay development and specific applications of interest.

 

Requested competences and skills:

Educational background: 

•    Ph.D. or Master degree in Biochemistry, Cell Biology, Molecular Biology or related scientific discipline with 3+ years of relevant experience.
•    4+ years in immunoassay development for an IVD and/or FDA product.

Work experience:

  • Experience in development of immunoassays.
  • Knowledge of protein detection techniques, such as ELISA, Western blot, SDS-PAGE, absorption spectroscopy, immunofluorescense, etc. 
  • Knowledge of the range of possible biomaterials that can be used in assay development such as antibodies, aptamers, nanobodies, and their industrial production techniques.
  • Experience in developing either a bacterial assay or a viral assay using immunoassay methodologies.
  • Experience with human sample handling and sample pretreatment methods.
  • Experience with human sample characterization.
  • In-depth knowledge and understanding of viral and/or bacterial infections.
  • Experience in assay development in a lateral flow type of format.
  • Experience in the development of assays according to CE-IVD and FDA regulations.
  • Excellent organisation, problem solving and computer skills. 
  • Fluent in English (written and oral). 
  • Flexible and able to work effectively independently as well as in a multidisciplinary team.
  • Ability to handle all external users in a professional manner.
  • It is a small team, bringing this new technology to a new market. This is why flexibility and the willingness to take up new and exciting tasks are necessary.

 

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