Jobs in life sciences

(Senior) assay developer

Ref. AD
Function: The (senior) assay developer will lead the development (team(s)) of (a) key assay(s) that will be brought to market.
Location: Ghent

The company:

The 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. 

Job description:

Mission

  • The (senior) assay developer will lead the development of a key assay that will be brought to market. Currently, two assays are earmarked for development, an assay for sexually transmitted infections and an assay for antibiotic stewardship to rule in/out a bacterial infection. 
  • The (senior) assay developer will be responsible for the development of one of the current products and possibly others in the future. 
  • In relation to seniority, the assay developer will lead 2 or more assay development teams. 
  • They 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: a combination of high-level desk work with rigorous and efficient lab-work. The company’s team is a startup with strict timelines and milestones in order to bring this product to market by end 2022.

Responsibilities

  • These encompass antibody selection, antibody deposition conditions, general assay protocol, testing user-flow and a deep biological understanding of all the aspects of the assay. Input is expected for the panel selection as well. It is expected of the assay developer to develop the assay starting from in-house built R&D cartridges to industrially assembled cartridges. The company is developing both products according to IVD and FDA design control methodologies and the assay developer is responsible for the planning and documentation according to both regulatory standards. 
  • The assay developer is responsible for the optimalisation and industrialisation of the linking layer that links a silicon substrate to an antibody is required as well. This encompasses increasing the robustness & stability of the functionalization protocol, upscaling the method and doing feasibility on potential alternative methods.
  • The assay developer will work closely with COO/technical 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.
  • Planning and execution of experiments in the framework of assay development projects with a focus on the FDA and CE-IVD development.
  • Upscaling and industrialisation of the functionalisation of the silicon surface to ready it for antibody deposition. 
  • Increasing the stability and the robustness of the biological functionalisation method from linking layer to antibody deposition.
  • In a later stage the assay developer will be responsible to develop a labelled approach to increase sensitivity.
  • Data analysis, data interpretation and reporting in the form of documents (closing reports, data summaries, etc.) and oral presentations (status updates, lessons learned, etc.)
  • 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
  • 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:

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 (immuno)assay development for an IVD and/or FDA product

Requirements

  • Experience in development of multiplexed assays for protein detection (antigen-antibody). 
  • Knowledge on protein detection techniques, such as ELISA, Western blot, SDS-PAGE and absorption spectroscopy.
  • Experience in the development of assays according to CE-IVD and FDA regulations.
  • Knowledge of ISO 13485. 
  • Excellent organisation, problem solving and computer skills. 
  • Knowhow and experience with labelling techniques is a plus.
  • 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. 
  • Holder of a valid driving license and willing to travel (national and international) to provide training and support to external users in the field. 
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