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.
Reporting to the COO/CFO, the Vice President of Point-of-Care Operations will be responsible for establishing an early launch to high-volume manufacturing capacity to maximize the Company’s growth in contribution margin while leading and managing the global point-of-care (POC) operations function. The successful candidate is a versatile and talented leader with a track record of achievement in the manufacture of plastic consumables with integrated reagents and diagnostic instruments. This person must have experience in design for manufacturability and have demonstrated experience in scaling to high-volume with cartridge and instrument contract manufacturers. The Vice President of Point-of-Care Operations will be highly adept in ensuring manufacturing operations are planned, resourced, and equipped to achieve the Company’s aggressive growth targets. This person must be a strong influential relationship builder with world-class manufacturing operations management experience.
- Provide day-to-day oversight and direction for all POC operations including cartridge and instrument CMO relationships, global supply chain and logistics, manufacturing engineering, and quality control activities.
- Identify and implement best practices in all aspects of operational effectiveness of the Company’s global contract manufacturing partners
- Oversee operations in compliance with FDA 21 CFR Part 820 Quality System Regulation
- Ensuring the quality, and on-time delivery of products by the company’s key contract manufacturers
- Ensure key suppliers and contract manufacturers are held accountable for performance and continuous improvement including lead time reduction, delivery, flexibility, quality improvement, inventory reduction (entire supply chain), and cost reduction. Utilize supplier scorecards to monitor and rate performance.
- Define and implement appropriate measurements and metrics including supplier KPI design and monitoring to create enterprise value
- Develop and implement strategic direction to the operation to ensure readiness for new product introductions
- Pursue efficiency improvements and cost reduction efforts consistent with corporate goals
- Lead collaboration with R&D and QA to ensure design transfer and quality targets are continuously achieved and improved
- Ensure effective prioritization, investigation, and resolution of findings impacting the Manufacturing operation identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation
- Implement the necessary systems and processes to adequately track and report on all operations activities.
- Develop, implement and maintain supply chain business continuity and disaster recovery programs
- Review performance against plans and standards, provide reports, interpret results and approve changes in plans
- Define objectives in each area of operations and develop short-term and long-term plans and programs, along with supporting the budget request and financial estimates
- Ensure that operating objectives and standards are understood by management and employees and develop systems for effective communication
- Supporting ongoing product development and cost reduction efforts by partnering with R&D, Quality Assurance, and strategic supplier partners to implement concurrent engineering and other collaborative approaches
- Assume other responsibilities from time to time as directed
Education, Experience, and Demonstrated Skills
- An advanced engineering degree or MBA
- A minimum of 15 years of management experience in an FDA-regulated manufacturing environment
- Proven senior-level medical device (ideally within complex IVD environment) operations experience at the VP level.
- Demonstrated experience in sourcing CMO partners and in designing and implementing high-volume manufacturing scale for IVD consumables and instrumentation
- Experience identifying and mitigating risks associated with design for manufacturing/assembly
- Experience in leading global high-volume contract manufacturing organizations
- Proven experience in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures
- Thorough familiarity is required with the FDA and CE Marking requirements and a proven track record of commercializing FDA regulated products on time and on budget
- Independent thinking, strong organizational and planning abilities, excellent analytical and problem-solving skills, strong business acumen, and the ability to multi-task are essential.
- A strong drive to succeed coupled with excellent interpersonal and leadership skills to coach, mentor, and tap the desire of employees to excel as individuals and on teams
- Tactful, decisive, get along with diverse personalities
- Proven ability to work effectively in a growth environment at multiple levels of management and company leadership; a true team player
- Result orientated, decision-maker with the ability to recognize and support the organizations’ priorities
- High level of communications skills, written and verbal. Articulate and persuasive
For interested applicants, please submit resumes to: firstname.lastname@example.org
binx health, Inc. is an Equal Opportunity Employer