QC Lead 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 broaden 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
binx health actively seeks a pro-active, enthusiastic individual with commercial QC experience, ready to be a leader within the QC team of our molecular platform. An independent experienced individual with significant QC / validation protocol development and execution is key. The role will involve the running of daily QC operations and co-ordinating the QC team. Release of final product, raw and formulated reagents, collection kits and the io reader. Troubleshooting test results, supporting operations and manufacture.
Responsibilities:
- Design and develop system-based nucleic acid assays
- Design and perform experiments, prepare technical reports and present results
- Optimise assays to meet performance specifications
- Data storage, analysis and trending including the generation of TMs, TRs, and VTRs.
- Evaluation and validation of assay performance against assay requirements, for both product release and stability.
- QC test method development, risk management and validation for raw materials, reagents and finished product (whole platform)
- Transfer laboratory-developed assays to both system prototypes and final cartridge
- Verification and validation of final product
- Development/preparation of quality system procedures and documentation
- Maintaining the QMS and company compliance to ISO13485 / 21 CFR Part 820 level
- Laboratory management and compliance: equipment calibration & maintenance along with cleaning / waste streams are major focus areas.
Qualifications
- BSc in relevant biological science, PhD preferred
- Commercial laboratory experience
- Working within a Quality Management System
- Previous experience within Quality Control
- Laboratory based, scientific background
- Working to & writing SOPs/work instructions
- Test Method Validation
- Working to QC procedures, methods & processes
- Preparation of reagents & materials to recipe
- Statistical analysis
- Equipment calibration & performance verification
- Working to timescales and deadlines
- Teamwork
- Ability to follow detailed procedures accurately
- Good self/time management
binx health, Ltd. is an Equal Opportunity Employer
For interested applicants, please submit resumes to: careers@mybinxhealth.com