Pediatric ELISA CLIA Lab Manager – Build-Out & Quality

150 Shriners Hospitals for Children; Portland (OR); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Tuition Assistance

Retirement Match

Job summary

Shriners Children's seeks an experienced Clinical Laboratory Manager to lead the establishment and ongoing operation of a nascent high-complexity CLIA laboratory focused on ELISA-based skeletal growth biomarkers in infants and children. The role encompasses pre-operational build-out through licensure, reporting to the CLIA Laboratory Director and Research Administrator.

The candidate will oversee daily lab operations, quality management, and regulatory compliance, including SOPs, KPI monitoring,

Qualifications

• Doctoral degree (MD, DO, PhD, or equivalent) in chemical, physical, biological, or clinical laboratory science with at least 1 year of high-complexity testing experience.
• Master's degree in chemical, physical, biological, or clinical laboratory science with at least 2 years of lab experience, including 6 months in high-complexity biochemistry testing.

Responsibilities

• Implement end-to-end CLIA-compliant testing workflows from specimen receipt to result reporting.
• Establish and maintain all CLIA SOPs and policies.
• Conduct analytical validation studies for ELISA-based testing.
• Coordinate submission and maintenance of the CLIA certificate.
• Establish and maintain a robust QMS aligned with CLIA requirements.
• Perform and supervise processing of patient specimens, including ELISA execution and instrument operation.
• Prepare and present monthly KPI reports to summarize performance and corrective actions.

Skills

High-complexity testing

Quality management

Regulatory compliance

Analytical validation

Education

PhD/MD/Equivalent

MS in lab science

Tools

ELISA platform

CLIA instrumentation

Job description

Shriners Children's seeks an experienced Clinical Laboratory Manager to lead the establishment and ongoing operation of a nascent high-complexity CLIA laboratory focused on ELISA-based skeletal growth biomarkers in infants and children. The role encompasses pre-operational build-out through licensure, reporting to the CLIA Laboratory Director and Research Administrator.

The candidate will oversee daily lab operations, quality management, and regulatory compliance, including SOPs, KPI monitoring,