Who we are

binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing for male and female samples. We also have a broad suite of offerings in sample collection 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 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 sample collection and laboratory 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

We are looking for a Production Manager to run our Reagents department.

Responsibilities

• Lead the setting up of a new cGMP/ISO13485 compliant production site for the manufacturing of binx formulated reagents for IVD/medical device product
• Lead process transfer, validation, and production scheduling activities
• Responsible for day-to-day site management, health and safety management, and waste management compliant with local regulations and liaise with site facilities managers
• Lead IQ/OQ of new equipment installed on-site
• Produce and implement equipment maintenance and calibration procedures
• Stock procurement, control, and designation of raw materials
• Liaise with binx operations and raw materials suppliers against binx production forecast
• Produce and maintain accurate records (plans, forms, and reports) for all activities
• Development/ preparation of quality system procedures and documentation compliant with ISO13485
• Responsible for training of production staff to binx procedures
• Line management of production staff

Education, Experience, and Demonstrated Skills

• BSC or PhD in a relevant scientific discipline
• 5 yrs+ experience in cGMP manufacturing of formulated reagents (pharma/ medical devices industry)
• Commercial in vitro diagnostic/medical devices product manufacturing experience
• Experienced in ISO13485 / cGMP compliance
• Line management of a production team
• Experienced in setting up and management of a production site
• Nucleic acid assay manufacturing experience
• Product Verification & Validation experience
• QC test method implementation and validation for raw materials, reagents, and finished product
• Regulatory experience to manufacture products for EU MDR 2017/745 and EU IVDR 2017/746
• Strong background in formulations manufacturing
• ISO13485 / cGMP compliance
• Equipment and process validation
• Production team management
• EU MDR 2017/745 and EU IVDR 2017/746 compliance
• Experience in bioinformatics and statistical analysis of data
• Experience in working with microorganisms to containment level II
• Experience working with eQMS systems
• Experience in autonomously managing projects
• Strong leadership skills
• Ability to work under pressure to tight deadlines
• Attention to detail & well organized
• Strong verbal & written communication (fluent in English)
• Competent in the use of Microsoft Office (Word Excel, PowerPoint, Teams)

binx health, Inc. is an Equal Opportunity Employer For interested applicants, please submit resumes to careers@mybinxhealth.com