Senior Manager, Clinical Genomics Laboratory Services
Regeneron Pharmaceuticals
Summary
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.
Job description
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
Requirements
- 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
- 2+ years of appropriate laboratory training/experience in the specialty
- Comprehensive knowledge of clinical quality requirements including CLIA, NY CLEP, and CAP
- Variant curation and data analyst experience (strongly preferred)
- Project management certificate (a plus)
Benefits
- Annual Bonuses
- Equity Awards
- Pension/Retirement Benefits
- 401(k) Matching
- Health & Wellness Programs
- Fitness Centers
- Medical, Dental & Vision
- Life & Disability Insurance
- Paid Time Off
- Family Support Benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.