Clinical Lab Director – Part-Time

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🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $0 - $1 / hour

⏱ Part Time

🔴 Lead

👨‍⚕️ Medical Director

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Spear Bio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2021

🧬 Biotechnology

🔬 Science

🤝 B2B

💰 $45M Series A - Spear Bio on 2024-07

Biotechnology • Science • B2B

Spear Bio is a biotechnology company that develops and sells ultra-sensitive protein biomarker detection assays and related reagents and services. Their proprietary SPEAR UltraDetect technology uses a two-factor authenticated, homogeneous (wash-free) format to detect trace protein biomarkers in single-molecule ranges from ultra-small sample volumes, and they offer assay kits (e. g. , pTau217, pTau231, GFAP, NF-L), reaction kits, automation accessories, data analysis, and evaluation/research accelerator services for applications in neurology, immunology, and infectious disease research.

📋 Description

• 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.

🎯 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