Manager/Director, Laboratory Operations - Genetics
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.