Director of Lab Operations ( {{city}})
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Manager/Director, Laboratory Operations - Genetics
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Durham, NC
We are seeking an experienced and highly motivated Manager/Director of Laboratory Operations with a strong background in clinical genetics. This pivotal role will oversee all operational aspects of our state-of-the-art clinical laboratory, ensuring the highest standards of quality, efficiency, and regulatory compliance, particularly as they pertain to genetic testing. The ideal candidate will be a strategic leader capable of optimizing workflows, fostering a culture of excellence, and driving innovation to support our mission of delivering impactful genetic insights.
Key Responsibilities:
Direct and manage all day-to-day laboratory operations, including sample accessioning, processing, testing, and reporting, with a strong focus on genetic assays (e.g., NGS, microarray, PCR-based methods).
Ensure strict adherence to all applicable regulatory requirements, including CLIA, CAP, and specifically the New York State Department of Health (NYS DOH) regulations for clinical laboratories performing genetic testing.
Stay abreast of new technologies and advancements in genetic testing and laboratory automation, evaluating and implementing solutions that enhance our capabilities and service offerings.
Provide expert guidance and solutions for complex technical and operational challenges within the genetics laboratory.
Qualifications:
Degree (Ph.D., M.D., or D.O.) in a chemical, biological, clinical, or medical laboratory science, or medical technology from an accredited institution.
Certifications/Licenses:
Valid Clinical Laboratory Technologist (CLT) Certificate of Qualification from the New York State Department of Education (NYSED) in Genetics is required.
Other relevant certifications (e.g., ASCP) are a plus.
Experience in a high-complexity clinical laboratory, with at least 3-5 years in a management or director role.
Extensive hands-on and leadership experience specifically in clinical genetic testing methodologies (e.g., Next-Generation Sequencing, Sanger Sequencing, Microarray, qPCR, FISH) and associated data analysis.
Demonstrated expertise in navigating and ensuring compliance with CLIA, CAP, and NYS DOH regulations.
- Location:
- Durham, North Carolina