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Posted on Joe Davin / in UK Jobs

Senior R & D Manager

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 manage 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.

The R&D manager reports directly to the R&D Director and is responsible for managing and delivering a wide range of R&D projects from menu development for the point-of-care diagnostic platform to improving and adapting current system tests to broaden the platform’s range of applications with proof of principle data. This position is responsible for ensuring that new products are developed within regulatory guidelines and development of the DHF as well as generating novel ideas to further take advantage of our proprietary electrochemical detection technology and broaden the applications. This diverse and exciting position requires high levels of organization and coordination across the business working interactively with the engineering group, QC, and QA as well as critical analysis of data and dissemination of results to wider audiences.

 

Responsibilities

· Management of the Research and Development team activities to deliver against project plans

. Developing new products within our menu that align with the company objectives

. Work closely with QA to ensure the design and development process is carried out with full regulatory compliance

. Work roactively and interactively across the business with the engineering operations and QC teams

· Lead in the technical direction of the development of new assays

. Report and update the CTO and technical leadership team on progress and progression towards milestones

. Flagging delays and any technical issues

· Ensure that the development and maintenance of the Design History File is fully compliant and conforms to the company’s design and development procedure

. Assist in the development of risk management activities and using the output to identify project priorities and define the human and financial resources for the team to meet agreed objectives

· Ensure that the laboratory facilities are running efficiently and within QMS and regulatory compliance

· Maintain current awareness of up-to-date regulatory requirements and technological advancements relevant to binx’s commercial objectives

· Maintain awareness of the clinical context for the areas in which binx has research activity

· Identify any novel aspects of the relevant project team’s work that could qualify for IP protection

 

Education, Experience, and Demonstrated Skills

. PhD in a relevant technical discipline

. BSc or First Degree in a relevant technical discipline

. Experience in effectively managing a team of 5-10 people in a busy and diverse environment

. Able to drive progress and inject enthusiasm and cohesiveness within the team

. Experience in project management of multi-disciplinary projects and working across teams to hit goals

. 7+ years of IVD product development experience, preferably in infectious disease diagnostics or related

. 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

. Clinical microbiology experience

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

. Demonstrate a high level of oral and written communication to deliver key messages across the business

. High level of organizational skills able to manage a diverse team working on multiple projects

. Ability to work with other teams and manage dependencies between projects

. Adaptable and demonstrated ability to make decisions and communicate these to technical leadership

 

 

binx health, Inc. is an Equal Opportunity Employer

For Interested applicants, please submit resumes to careers@mybinxhealth.com