High Complexity Lab Director

Insight Global; Ann Arbor (MI); On-site; USD 180,000 - 240,000; Full time

Job summary

Insight Global is seeking a High Complexity Laboratory Director to serve as the senior scientific and regulatory leader of its CLIA/CAP-certified molecular diagnostics laboratory. The role oversees operations, quality systems, regulatory compliance, assay implementation and future diagnostic product development, partnering with R&D, Quality, Medical Affairs and Operations teams.

This hands-on, onsite leadership position is based in Ann Arbor, MI and requires extensive experience directing

Qualifications

• PhD, ScD, MD, or DO degree satisfying CLIA educational requirements.
• Current certification by an HHS-approved board; ABB High-complexity Clinical Laboratory Director preferred.
• Hands-on experience with real-time PCR or RT-qPCR, nucleic-acid extraction, assay validation, QC and troubleshooting.
• Excellent technical judgment and written and verbal communication skills.
• At least two years directing or supervising high-complexity testing and at least 20 CE credits for director responsibilities.

Responsibilities

• Oversee laboratory operations and quality systems in a CLIA/CAP-certified molecular diagnostics lab.
• Lead regulatory compliance activities and assay validation/implementation.
• Drive future diagnostic product development in collaboration with R&D, Quality, Medical Affairs and Operations.
• Provide hands-on, onsite leadership and mentorship in Ann Arbor, MI.

Skills

RT-qPCR experience

Laboratory supervision

Technical communication

Regulatory knowledge

CE credits for director role

Education

PhD/MD/DO or equivalent with CLIA requirements

HHS-approved board certification (LDT director)

Continuing education credits for laboratory-director responsibilities

New York State Certificate of Qualification in molecular oncology and genetic testing

Job description

Insight Global is hiring a High Complexity Laboratory Director for an emerging healthcare client to serve as the senior scientific and regulatory leader of its CLIA/CAP-certified molecular diagnostics laboratory. This individual will oversee laboratory operations, quality systems, regulatory compliance, assay implementation, and future diagnostic product development while partnering closely with R&D, Quality, Medical Affairs, and Operations teams. This is a hands-on, onsite leadership role based in Ann Arbor, MI.

Required Skills & Experience

• PhD, ScD, MD, DO, or equivalent doctoral degree that satisfies the current CLIA educational requirements.
• Current certification, maintained in good standing, by an HHS-approved board. ABB High-complexity Clinical Laboratory Director certification in Molecular Diagnostics is preferred.
• Hands-on experience with real-time PCR or RT-qPCR, nucleic-acid extraction, assay validation, quality control and troubleshooting.
• Excellent technical judgment and written and verbal communication skills.
• At least two years of applicable clinical laboratory training or experience, at least two years directing or supervising high complexity testing, and at least 20 continuing-education credit hours covering laboratory-director responsibilities, unless a current grandfather provision applies.

Preferred Qualifications

• New York State Certificate of Qualification in molecular oncology and genetic testing
• Experience supporting a high-throughput clinical laboratory, including assay performance monitoring, workflow improvement, automation, and laboratory information systems.
• Prior experience mentoring or supervising technical personnel.