The first homogeneous immunoassay platform offering unmatched sensitivity with scalable simplicity.
Clinical Lab Director – Part-Time
Location
Massachusetts
Posted
5 days ago
Salary
$0 - $1 / hour
Seniority
Lead
Job Description
Clinical Lab Director – Part-Time
Spear Bio
• Serve as the CLIA Laboratory Director for Spear Bio’s high-complexity clinical laboratory. • Provide overall clinical, scientific, and regulatory oversight of CLIA-certified laboratory operations. • Ensure compliance with all applicable regulatory and accreditation requirements, including CLIA, CAP, and NY State CLEP, as applicable. • Oversee quality management program to ensure accurate, reliable, and timely laboratory testing. • Review and approve laboratory policies, procedures, test validations, and quality documentation. • Monitor laboratory performance and implement continuous quality improvement initiatives. • Provide clinical consultation to physicians and other healthcare providers regarding laboratory testing and test results. • Support laboratory readiness for regulatory inspections and accreditation surveys. • Foster a culture of quality, compliance, and scientific excellence.
Job Requirements
- M.D., D.O., or Ph.D. in a relevant scientific discipline (e.g., immunology, pathology, clinical chemistry, biochemistry, molecular biology, or a related field)
- Qualified to serve as Clinical Laboratory Director of a high-complexity CLIA laboratory under applicable federal and Massachusetts state regulations -- Clinical Laboratory Director License issued by the Massachusetts Department of Public Health (MDPH) is required
- Board certification in a relevant discipline (e.g., Clinical Chemistry, Clinical Pathology, HCLD, Immunology, or other appropriate specialty) is required
- Minimum 8-10 years of experience in high complexity clinical laboratory operations, with at least 5 years in a director-level role overseeing a CAP/CLIA-certified laboratory.
- Proven track record of successfully establishing or scaling a clinical lab.
- Demonstrated expertise in immunoassay technologies (such as Immuno assay PCR, or digital ELISA), assay validation and verification.
- Strong knowledge of laboratory quality systems, proficiency testing, and inspection readiness.
- Experience with LIMS platforms, electronic quality management systems (eQMS), and workflow automation in a high-complexity testing environment.
- Experience working for a fast-paced, early-stage startup.
Benefits
- competitive compensation
- meaningful stock ownership
- comprehensive benefits
- great work environment
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