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.
We are looking for an Operations Manager to join our Point of Care Operations team. This role will be responsible for monitoring and managing our 4 contract manufacturers in their week-to-week performance of operations. The Operations Manager will establish metrics and process oversight for yield, equipment performance (OEE), and product cost reduction. The Operations Manager will also provide oversight and budget management for equipment maintenance and replacement schedules.
- Lead production planning activities as part of a tiered SIOP model.
- Cost Management
- Capital investments for replacing equipment
- Expense planning for maintenance (PPM)
- Equipment upgrades
- Identifying, prioritizing, and Managing Execution of Efficiency Initiatives in collaboration with the bing and CMO engineering groups.
- Escalation and raise awareness of risks and issues affecting manufacturing and product supply.
- Collaborate with and manage internal and external resources to find a resolution to production impacting risks and issues.
- Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation.
- Supporting the VP of Operations in developing and driving strategic and operational improvement throughout the business.
- Be an ambassador for LEAN processes and Operational Excellence: Instill a culture of continuous process improvement with a quality focus
- Pursue industry “best practices” associated with clinical and commercial production operations.
- Collaborate with Supply Chain colleagues to ensure customer satisfaction.
- Produce and maintain working practices and procedures appropriate to the role, ensuring that policies are followed for ISO13485, cGMP.
- Review Master Batch Records, SOPs, Qualification/Validation protocols, and reports, and other essential cGMP documents.
- Write and revise Standard Operating Procedures and other operational documents as needed.
- Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion
- Any additional function as may be required to meet the evolving needs of the business
Education, Experience, and Demonstrated Skills
- Business, operations/logistics-related Bachelor’s degree (Or equivalent experience)
- Medical device manufacturing (or equivalent regulated environment)
- 3+ years of leadership experience
- 7+ years of operational/manufacturing process management
- Experience developing and implementing SOP’s
- Industry best practices to improve existing processes (One of SixSigma, LEAN, OpEx, BEX).
- Ability to effectively engage with key stakeholders at the executive management level & effectively scale communication style for executive audiences.
- Strong analytical skills (working knowledge of Excel) and numeracy skills
- Experienced in managing third parties.
- ERP usage including SIOP at the business unit level
- Strong oral and written communication skills
- Results-oriented and process driven
Employees may be required to lift routine office supplies and use office equipment. The majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Travel will be required both nationally and internationally ranging from 5% to 40% of any given month as business and project require.
binx health, Inc. is an Equal Opportunity Employer
For interested applicants, please submit resumes to: email@example.com