Director of Operations (CLIA/CAP)

Biofidelity’s mission is to improve and extend the lives of patients with cancer by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care. 

At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges. 

Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including medical, dental and vision cover, 401(k), bonus, share option scheme, 20 days per year PTO allowance and 2 floating holidays in addition to Company observed holidays.

Biofidelity is seeking an experienced, efficient, dynamic and results-oriented Director of Operations (CLIA/CAP) to plan, develop, organize and steer CLIA/CAP lab operations and performance. The ideal candidate has excellent project management and organizational skills, is collaborative and finds solutions with an empathetic approach that gets results. This role reports to the Chief Operating Officer.

Key responsibilities:

• Direct CLIA/CAP lab set-up, implementing all processes and standards to ensure operational efficiency in line with regulatory compliance and best practices

• Responsible for the day-to-day running and maintenance of the facility 

• Responsible for the overall management of the laboratory, including administration, logistics, procurement, safety and hiring of other laboratory staff

• Establish and maintain quality control, including quality assurance of assays and incoming materials

• Implement and maintain supporting software systems including EQMS and LIMs

• Work on continuous improvement of all processes to increase efficiency

Knowledge, Skills and Abilities:

• Strong understanding of CLIA/CAP regulatory requirements 

• Experience with clinical qPCR, NGS or other clinical laboratory testing in molecular oncology

• Detail-oriented and practical, yet with the ability to understand strategic direction

• Strong influencing, communication, organizational and leadership skills

• Possesses entrepreneurial and flexible mindset and ability to multitask in a small, fast-growing company

 Requisite Education and Experience / Minimum Qualifications:

• Proven experience in leading operations in CLIA/CAP certified laboratory

• Degree educated in scientific field

• Previous experience in diagnostics

• Previous line management experience