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Posted on Alex Kramer / in UK Jobs

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 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

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 coordinating the QC team. Release of the 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
  • Optimize 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.

Education, Experience, and Demonstrated Skills

  • BSc in relevant biological science, Ph.D. 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