Senior Assay Developer

29/06/20

Location

Industriepark-Zwijnaarde 7C Zwijnaarde Belgium

Function type

Senior Scientist

Vacancy

Mission

Antelope is developing a home testing platform. The Antelope 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.

Antelope is developing a “menu” for the self-testing market, with the 2 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. Antelope is developing both products according to IVD and FDA design control methodologies and the senior assay developer is responsible for the planning and documentation according both regulatory standards.

Role

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.

We are a small team bringing this novel technology to a new market such that flexibility and the willingness to take up new and exciting tasks is necessary.

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 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

Required education/training

  • 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

Requirements (e.g.: work experience)

  • 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:

    • Development of immunoassays.

    • Developing either a bacterial assay or a viral assay using immunoassay methodologies.

    • Human sample handling and sample pretreatment methods.

    • Human sample characterization.

    • Assay development in a lateral flow type of format.

    • Development of assays according to CE-IVD and FDA regulations.

  • In-depth knowledge and understanding of viral and/or bacterial infections.

  • 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.

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