Director of Operations (CLIA/CAP)
RTP, North Carolina
Biofidelity’s mission is to improve and extend cancer patients’ lives 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 teamwork, openness and trust. 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 setbacks.
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.
Set up CLIA/CAP lab, design and implement all processes and standards to ensure operational efficiency of the CLIA/CAP lab in line with regulatory compliance and best practices
Responsible for the overall management of the laboratory, including administration, logistics, procurement, and hiring of other laboratory staff
Establish and maintain quality control and quality assurance of assays and incoming materials
Implement CRM and LIMs systems
Liaise with R&D, IT, clinicians, Lab Director, and other stakeholders
Work on continuous improvement of all processes to increase efficiency
Knowledge, Skills and Abilities:
Strong understanding of CLIA/CAP regulatory requirements
Detail-oriented, practical, yet with the ability to understand strategic direction
Strong influencing, communication and organizational skills
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
To apply, please email your CV and cover letter to firstname.lastname@example.org.
We are seeking a talented Bioinformatician to play a pivotal role in developing and implementing bioinformatic solutions across our product development pipeline.
We are seeking a Laboratory Medical Director to direct and supervise CLIA/CAP lab testing and performance while ensuring all aspects of relevant regulatory and accreditation requirements are met.
We are seeking a highly motivated and adaptable Associate Director of Product Development to lead the development and life-cycle management of new testing services.