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Posted on Joe Davin / in UK Jobs

Commercial Reagent Specialist

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

Management of the assay formulated reagent designs throughout development, transfer to manufacturing, scale-up, and obsolescence. Highlighting and pro-actively driving reagent design critical to quality parameters. Leading stability/handling studies and aiding QC test method development, implementation, and risk management for effective manufacture. Supporting R&D, QC, and Operation departments to meet corporate goals as well as collaborating with key CMOs to ensure efficient, continued supply of high-quality materials for manufacture. Leading standardized chemical formulation calculations and being the authority on applied chemistry principles within the business, acting as a mentor to the team. Interacting with, and continued improvement of, the DHF to drive continual improvement within the assay sphere.

 

Responsibilities

  • Management of the assay reagent designs
  • Identifying, management of and project support of potential and existing CMOs in relation to reagent supply and manufacture.
  • Working collaboratively with both internal and external parties to ensure a high level critical to quality control of the formulated reagents both at R&D, Commercial manufacture, and scale-up.
  • Authority figure in applied chemistry principles and their application, particularly around the formulation and chemical calculations.
  • Reagent and chemical safety, risk management, and regulatory oversight
  • Maintaining the QMS and company compliance to ISO13485 / 21 CFR Part 820 level

 

Education, Experience, and Demonstrated Skills

  • BS in computer science or related discipline, or equivalent work experience
  • BSc in a relevant scientific discipline
  • Ph.D. in a relevant scientific discipline
  • Significant (at least 5 years) relevant technical experience within commercial applied reagent/chemistry focused job
  • Management of external CMOs within the reagent supply chain.
  • Responsibility role (or equivalent) demonstrating project
  • management to deliver key program objectives
  • Commercial in vitro diagnostic product development experience
  • Commercial scale-up experience
  • Product Verification & Validation experience
  • Work to Quality Management & Regulatory framework
  • Experience working within ISO13485 and/or 21 CFR Part 820
  • Strong applied chemistry laboratory-based background ü
  • Experimental design, data analysis and problem-solving ü
  • Experience in complex chemical formulation calculations ü
  • Molecular assay development and optimization – particularly PCR
  • Experience in designing multiplex PCR assays
  • Experience in working with microorganisms to containment level II
  • Experience in autonomously managing projects
  • Good presentation technique
  • Strong verbal & written communication
  • Working to deadlines
  • Attention to detail & well organised
  • Competent in word processing, spreadsheets, database

 

binx health, Inc. is an Equal Opportunity Employer

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