Assistant Laboratory Director

Dormont Manufacturing Co; Austin (TX); On-site; USD 134,000 - 168,000; Full time

Job summary

Natera is seeking a Laboratory Director to oversee our clinical laboratory testing, ensure regulatory compliance, and guarantee accurate patient results. This senior role leads a team, sets testing standards, and supports genetic counselors and staff, with a focus on quality and reliability in molecular testing.

The position requires advanced genetics credentials, board certification, and robust CLIA-level experience.

Qualifications

• MD/DO and/or PhD in genetics or related field required.
• ABMGG board-certified in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required.
• Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Cytogeneticist required.
• Current Certificate of Qualification in Genetic Testing from the NYS CLEP required.
• 5 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data.

Responsibilities

• Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results.
• Oversee the review of genetic and CNV variant data and interpret results in context of literature and databases.
• Provide clinical and technical support for genetic counselors and laboratory personnel.
• Set standards for laboratory testing and analytic performance; ensure maintenance.
• Analyze lab data and contribute to publications in scientific journals.

Skills

Communication skills

Genetics expertise

Leadership

NGS & CNV analysis

Genetic testing statistics

Education

MD/DO or PhD in genetics

ABMGG/ABP board certification

California laboratory director license

NYS CLEP qualification

5+ years CLIA laboratory experience

Tools

None

Job description

POSITION SUMMARY

As the Laboratory Director and one of our Laboratory Directors, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results.

PRIMARY RESPONSIBILITIES:

• Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and oncology testing on platforms including SNP array analysis, NGS, and other methodologies.
• Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data.
• Provide clinical and technical support for genetic counselors and other laboratory personnel.
• Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained.
• Analyze lab data, contribute to or write publications for high-quality scientific journals.

May serve as Clinical Consultant. The Clinical Consultant is responsible for ensuring:

• Test reports include pertinent information for test interpretation, and
• Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions

May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring:

• Appropriate test method selection
• Adequate method verification to determine the accuracy and precision of the test
• Enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed
• PT samples are tested in accordance with the CLIA requirements
• PT results are returned within the time frames established by the PT program
• PT reports are reviewed by the appropriate staff
• Corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory
• Quality assessment and quality control programs are established and maintained
• Acceptable analytical test performance is established and maintained for each test system
• Remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly
• Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens
• Policies and procedures are established for monitoring personnel competency in all phases (preanalytical, analytical, and postanalytical) of testing to assure the ongoing competency of all individuals who perform testing;
• remedial training or continuing education needs are identified, and training provided; and an approved procedure manual is available to all personnel.

Manage a team:

• Review and approve assigned work; mentor and develop personnel, including dedicated succession planning and contingency management.
• This role works with PHI on a regular basis both in paper and electronic form and has an access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and ProcedureCompliancetraining and security training as soon as possible but not later than the first 30days of hire.
• Must maintain a current status on Natera training requirements.
• Employee must pass post offer criminal background check.

QUALIFICATIONS:

• MD/DO and/or PhD in genetics or related field required.
• ABMGG board-certified in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required.
• Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Cytogeneticist required.
• Current Certificate of Qualification in Genetic Testing from the NYS CLEP required.
• 5 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data.
• Knowledge of CAP, CLIA, California, and New York state regulations.
• Management experience required.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent written and oral communication skills.
• Experience leading a laboratory offering prenatal screening and oncology testing and evaluating, interpreting, and reporting out NGS and microarray data.
• Familiarity with next-generation sequencing, and/or knowledge of advanced methods of copy number detection.
• Strong background in human and medical genetics, and oncology with a familiarity of online human genomics.
• Understanding of statistical measures utilized in genetic testing and screening.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in BSL-2 lab setting.
• Standing or sitting for long periods of time may be necessary.
• Duties may require working various shifts, weekends, and/or overtime.

Travel required for this position:

No or Yes: If yes state anticipated percent for travel: up to 10%

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Austin, TX

$134,100—$167,600 USD

OUR OPPORTUNITY

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/