Senior Manager, Clinical Genomics Laboratory Services

Regeneron Clinical Genomics Laboratory LLC

United States

On-site

USD 137,000 - 224,000

Full time

4 days ago
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Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager for Clinical Laboratory Services in Tarrytown, NY.

This role oversees the daily operations of the Clinical Genomics Laboratory, ensuring compliance with CLIA, NY CLEP, CAP, and NYSED credentials, while leading a team in variant classification and data analysis. The position emphasizes hands-on oversight, quality improvements, and documentation in line with regulatory standards, with a focus on keeping operations on-site four days per

Qualifications

  • Doctoral degree in a chemical, physical, biological, or clinical laboratory science (or medicine).
  • New York State Technologist License or Technical Director in Genetic Testing with 5+ years in an NGS clinical lab.
  • Variant curation and data analyst experience preferred.
  • 2+ years of appropriate laboratory training/experience in the specialty.
  • Project management certificate is a plus.

Responsibilities

  • Direct and oversee daily NextGen Sequencing clinical laboratory operations, including workflow, sample processing, testing, and post-analytical processes.
  • Provide operational leadership and technical guidance, define scope of work, and drive execution to deliver results in a fast-paced environment.
  • Ensure regulatory compliance with NYS DOH, CLIA, CAP and other accrediting bodies through monitoring of processes.
  • Implement and monitor quality control procedures for accurate results.
  • Participate in test validation, performance evaluation, and verification of assays.
  • Lead, mentor, and develop laboratory staff to foster accountability and professional growth.
  • Analyze quality indicators, track trends, and report critical compliance risks.

Skills

Operational leadership
Regulatory compliance
Data analysis

Education

Doctoral degree in chemical/physical/biological/clinical lab science or medicine

Tools

NextGen Sequencing platforms

Job description

Build Our Future Together

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.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $137,100.00 - $223,500.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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