FDA grants binx health CLIA-Waiver for its first-of-kind binx io platform for chlamydia and gonorrhea testing

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Posted on Joe Davin / in UK Jobs

Research and Development Scientist

Who we are

binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing. We also have the broadest suite of offerings in at-home testing for large corporate partners for broadened access to STI and COVID-19 care.  Our molecular point of care platform brings rapid, accurate and convenient infectious disease testing to people where they live, work and shop. Our at-home solutions offer front-end engagement, and end-to-end logistics in concert with our reference lab partners to offer partners “turn-key” answers for their infectious disease testing needs. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. Our suite of medical guideline-driven, at-home testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.


The Position

You will work within a team of R&D scientists and engineers in a quick-moving, diverse and pro-active environment to assist in the development of new tests for our novel and proprietary point of care diagnostic platform. You will play a key part in contributing to the further development of a range of applications and assays on our unique io platform that is a world-first in molecular diagnostics providing laboratory-quality results in 30 minutes. This exciting opportunity will expand the menu of tests that help patients receive a quick diagnosis when they need it and clinicians to truly operate a test and treatment environment.



· Assist in the design & development of system-based nucleic acid assays

.  Compose well-structured experimental plans

· Advise on and analyze complex data sets including statistical analysis

· High-quality execution of laboratory experiments

· Optimisation of assays to meet performance requirements and ensure patient safety.

· Transfer of bench-developed assays to system prototypes.

· Laboratory report writing & presentation of results

· Research and development, testing, and validation of the performance of assay reagents and assay protocols.

· Follow and engage in the Quality Management System


Education, Experience, and Demonstrated Skills

. Ph.D. in a relevant technical discipline

. BSc or First Degree in a relevant technical discipline

. 3+ years of IVD product development experience, preferably in infectious disease diagnostics

. Experience of working within multi-disciplinary projects and across teams to hit goals

. Significant knowledge and experience working to meet regulatory requirements of the IVDD and FDA for IVDs

. Molecular biology knowledge and demonstrated application to the development of infectious disease assays

. Strong analytical data analysis skills including application of appropriate statistics to interpret data

. Working knowledge and application of Design History, File documentation and Design and Development process

. Experimental design, data analysis & problem-solving

. Microbiology to class II containment level

. PCR integration onto plastic disposable devices

. Clinical microbiology experience

. Experience in qPCR and analysis

. Demonstrated high level oral and written communication skills to deliver key messages across the business

. High level of organizational skills and ability to manage dependencies between projects

. Proven ability to work to project timescales/deadlines

. Working within a team to achieve company goals


binx health, Inc. is an Equal Opportunity Employer

For Interested applicants, please submit resumes to