CLIA Lab Director, Technical Consultant

Lighthouse Lab Services is looking for a Laboratory Director / Technical Consultant with Molecular / Infectious Disease expertise to join our Consulting team!

This is a full-time, remote/ work-from-home position with some national travel up to 30%.

Snapshot / What You'll Do:

The Laboratory Director and Technical Consultant focuses on the technical operations for start-up laboratories, or other consulting projects for existing laboratories such as adding additional lines of testing. Collaborating with our Project Management, Field Ops, Quality, and Recruiting teams, this role ensures laboratory buildouts are completed compliantly and within projected timelines.

The position involves a broad range of consulting responsibilities. These include recommending appropriate laboratory equipment, assisting in laboratory design and build-out, developing standard operating procedures, creating test menus, and supporting method development. You will also validate instrumentation, oversee correlation and specimen stability studies, and respond to client inquiries. 

Essential Functions and Basic Duties, includes but not limited to:

• Serve as the CLIA Lab Director of Record for up to five laboratories, as assigned by the Company.
• Execute strategic project planning, organization, and management of multiple client projects at a variety of stages of development, eensuring compliance with CLIA, accreditation organizations, and all applicable federal, state, and local regulations.
  • ​​​​​​​Provide recommendations on instrumentation, test menus, and overall laboratory setup based on client needs.
  • Collaborate with clients and instrument manufacturers to plan laboratory layout and design, ensuring optimal workflow and compliance.
  • Lead or support the validation of instrumentation, including general and technical SOP development.
  • Prepare client laboratories for inspections and initial surveys conducted by accrediting or licensing agencies.
  • Oversee the implementation of proficiency testing systems and other CLIA-mandated quality and regulatory requirements.
  • Assist clients with additional tasks, special projects, and operational duties as needed.
• Advise on laboratory troubleshooting and best practices.
• Identify areas for improvement and contribute to process improvement initiatives in collaboration with the Chief Consulting Officer and leadership team.
• Serve as a point of contact for client communications, providing timely responses to questions and concerns.
• Foster strong client relationships through transparent, solution-oriented communication.
• Support a team-based approach by maintaining high-level collaboration and professional communication across departments and with clients.
• Continuously expand subject-matter expertise and stay informed of emerging technologies and industry trends.

Qualifications:

The candidate will be expected to meet the qualifications provided by the relevant regulations (including those provided by CLIA, 42 C.F.R. § 493.1443) for directing and supervising a high complexity laboratory, including:

• For PhDs: The qualification for a laboratory director of high-complexity testing is that the laboratory director must hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.  The current approved boards are the following:
  • 1. ABB – American Board of Bioanalysis
  • 2. ABB public health microbiology certification
  • 3. ABCC – American Board of Clinical Chemistry
  • 4. ABCC 24-month Commission on Accreditation in Clinical Chemistry (COMACC)
  • 5. ABFT – American Board of Forensic Toxicology
  • 6. ABHI – American Board of Histocompatibility and Immunogenetics
  • 7. ABMG – American Board of Medical Genetics
  • 8. ABMLI – American Board of Medical Laboratory Immunology
  • 9. ABMM – American Board of Medical Microbiology
  • 10. NRCC – National Registry of Certified Chemists

Experience and Skill Requirements:

• 3+ years of method development in a CLIA infectious disease laboratory setting is preferred.
• Validation of methods in a clinical setting.
• Experience with clinical laboratory regulatory requirements.
• Experience preparing for and leading laboratory accreditation and licensing surveys and
  inspections.
• Working knowledge of clinical laboratory science, operational best practices, and instrument
  theory and operation.
• Previous experience writing SOPs for a variety of specialties and subspecialties in the clinical laboratory setting.

Salary and Benefits:

• Salary range between $120,000-130,000 annually
• Medical, Vision, and Dental Benefit offerings
• 15 days Paid Time Off (vacation and sick days)
• 9 Paid Holidays
• 401(k) retirement plan with up to 4% Company match
• Company-provided group life + AD&D, short and long-term disability insurance
• Paid Volunteer Time Off
• Partially Paid Medical Leave / Paid Parental Leave

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities. If at any time during the application process, you need an accommodation, please contact [email protected] for assistance.

Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com