Description Lead Scientist, Product Development Who We Are binx health is a healthcare technology and diagnostics company focused on expanding access to care. The binx io is the world’s first FDA-cleared, CLIA-Waived, point-of-care platform for chlamydia and gonorrhea testing in both males and females. Our rapid, molecular platform brings rapid, accurate and convenient infectious disease testing to clinical settings nationwide. binx everywhere is our technology platform that provides the necessary tools to connect your community with convenient diagnostic testing programs through self-collected samples, high-quality laboratory partnerships, and a full continuum of clinical care where and when it’s convenient for them. Our solutions have the ability broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere. We work with universities, hospitals, clinics, public health departments, k-12 schools, employers and other organizations to provide patient-centric solutions for their communities. Our Values We are… B old – Tenac i ous – O n e Team – Fi x ated on Our Mission At binx health, we know a diverse workforce adds to our collective value and strength as an organization. People of colour, the LGBTQIA community, disabled candidates and veterans are strongly encouraged to apply. binx health is proud to be an Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. The Position The position is within the Product Development team based in Trowbridge, UK working within a multidisciplinary scientific team to develop new products and processes associated with our novel and proprietary PoC Nucleic Acid Amplification Test (NAAT) diagnostic platform, the binx io. This position will involve leading a small team of scientists in an innovative and collaborative scientific environment. You will manage technical development projects from inception to implementation / design transfer. The Lead Scientist position is primarily laboratory-based, however, a significant proportion of time will be spent in technical project management, reporting, and stakeholder management. The Lead Scientist will lead by example and cultivate a supportive, collaborative, and rigorous scientific culture, while ensuring projects are delivered to a high technical standard and in a timely manner. Responsibilities T echnical lead across multiple projects within the Product Development department Lead a group of 2-3 assay development scientists Develop and author complex experimental plans, manage experimentation by scientific group, and perform data analysis and experimental write ups. Develop and track goals and objectives for line reports to achieve binx company goals and develop personnel. Develop and execute short term (1-6 months) technical project plans and schedules for the optimisation of molecular biology and electrochemistry based assays and test methods Lead risk management activities according to ISO 14971 to develop technical plans for projects Lead on optimisation technical strategy for assays and test methods Design and execute experiments according to Robust Design / Design of Experiments principles Subject matter expert for statistical analysis of experimental outcomes, guide other team members in the most appropriate tests and interpretations Author and maintain Design Control / Design History File documentation Prepare technical reports summarising project outcomes and findings that lead into design decisions Ensure all development activities are conducted and documented in compliance with binx Quality Management System Foster a proactive, collaborative, and open culture within the Product Development group Lead by example, set and maintain a high standard of output and attitude Promote exceptional laboratory practices to the scientific staff Education, Experience And Demonstrated Skills Typically requires a 7 years of related experience with a Bachelor’s degree; or 5 years and a Master’s degree or PhD. Essential Industrial NAAT IVD assay development experience Strong and proven understanding of Design Control of IVD devices compliant with ISO 13485 Data management and data analysis experience using Excel Working within and creating processes for Quality Management and Regulatory frameworks Understanding of the application of Robust Design and Design of Experiments techniques and principles Strong laboratory-based background Excellent organisational and time-management skills for self and team Proven ability to plan and run tactical technical projects independently and successfully A logical and methodical approach to solving problems and investigations Strong understanding and ability to coach on: Experimental design, data analysis, and communication of results Technical data presentation Verbal & written communication Word processing, spreadsheets, data analysis tools Self-motivated and willing to learn Attention to detail & well organised Proven track record in creating and improving processes Advantageous MSc or PhD in a biology or chemistry-based scientific discipline Strong and proven background in Robust Design and Design of Experiments techniques and principles Lean Six Sigma accreditation Verification and validation of equipment or products In depth understanding and use of Minitab, JMP, R, SPSS, MATLAB, Python, databases Previous multi-person technical project management experience