Full Job Description
Reporting to the Clinical Laboratory Director, the Senior Manager, Clinical Laboratory Services oversees and manages the daily operations of the Regeneron Clinical Genomics Laboratory, ensuring compliance with all regulatory requirements. The role combines hands-on, end-to-end oversight of complex laboratory tests and procedures with stakeholder collaboration, data analysis, participation in test validation, and the writing and maintenance of laboratory documentation in accordance with regulatory standards. The Senior Manager also serves as the scientific lead for variant classification decisions and leads quality and continuous improvement efforts, including implementing changes to mitigate risks. The role includes leading, training, and mentoring team members in clinical laboratory procedures. This position requires comprehensive knowledge of clinical quality requirements, including CLIA, NY CLEP, and CAP, and NYSED-issued credentials as a Clinical Laboratory Technologist or Technical Director.
When & where:
• Work Location: Tarrytown, NY
• Work model/flexibility: 4 days per week on site
Discover your role:
• Direct and oversee daily NextGen Sequencing clinical laboratory operations, including workflow, sample processing, testing, and post-analytical processes, to ensure efficient and accurate functioning.
• Provide operational leadership and technical guidance, present organizational capabilities, define the scope of work, and drive execution to deliver results in a fast-paced environment.
• Ensure operational adherence to all regulatory standards and maintain compliance with New York State Department of Health regulations, CLIA and CAP guidelines, and requirements of other relevant accrediting agencies by monitoring and reviewing laboratory processes and procedures. Implement and monitor quality control procedures to guarantee accurate and reliable test results.
• Participate in design and performance of test validation processes, including method validation, performance evaluation, and verification of assays.
• This role may serve as Variant Scientist, supporting technical analysis, curation, and classification of all genetic variants identified in patient samples. This requires the use of laboratory platforms for variant prioritization and automated ACMG classification scoring.
• Assist in the development and maintenance of required documentation, including work instructions/SOPs, policies, and protocols.
• Promote a continuous improvement mindset and identify opportunities for process enhancements and risk mitigation.
• Analyze and report quality indicators, tracking trends, and communicating critical compliance and quality risks.
• Provide people leadership to laboratory staff, including hiring, training, mentoring, performance management, and day-to-day supervision, fostering a culture of accountability and professional growth.
This role requires:
• A doctoral degree in a chemical, physical, biological, or clinical laboratory science (or medicine) from an accredited institution.
• Valid full New York State Technologist License or Technical Director in Genetic Testing
• 5 + years of experience working in a next generation sequencing clinical laboratory. Strongly preferred: Variant curation and data analyst experience.
• 2+ years of appropriate laboratory training/experience in the specialty
• Project management certificate is a plus
Salary Range (annually)
$137,100.00 - $223,500.00
