What are the responsibilities and job description for the High Complex CLIA LAB: Lab Director position at Nanobiosym?
Nanobiosym is an innovative company in Cambridge, MA that is developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. This hypergrowth company allows for unique career opportunities with strong long-term incentives. Nanobiosym is currently seeking top notch candidates to help the company scale up its operations.
seeking a part-time/full time Laboratory Director to support the establishment, certification, and operation of our CLIA-certified laboratory in Massachusetts. The Laboratory Director will provide clinical, scientific, and regulatory oversight to ensure Nanobiosym delivers accurate, reliable, and high-quality testing services in compliance with applicable regulatory and accreditation requirements, including CLIA, CAP, and other applicable state requirements.
The Laboratory Director will be responsible for overseeing laboratory QMS, ensuring appropriate validation and performance of all testing methods, reviewing laboratory procedures, and supporting continuous improvement initiatives. This role provides clinical and technical guidance for test interpretation, quality assurance and regulatory compliance.
This is a role intended to support Nanobiosym's CLIA/CAP certification readiness and clinical laboratory operations. The Laboratory Director may delegate specific duties to qualified personnel but retains the ultimate responsibility for ensuring these duties are properly performed and documented.
Responsibilities:
- Serve as the CLIA Laboratory Director for our high-complexity clinical laboratory.
- Provide overall clinical, scientific, and regulatory oversight of CLIA/CAP-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.
Qualifications
- M.D., 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/CAP 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., Virology, Molecular Biology, 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 molecular diagnostics for 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, growing organization