Natera is currently seeking a high-energy dynamic individual, who is board-certified in Clinical Molecular Genetics, to help head our Austin Texas laboratory. The Austin Laboratory Director must come to Natera as a team player with excellent communication skills. As Laboratory Director, you will be required to make clinical decisions at a rapid pace and interact with laboratorians and genetic counselors on a daily basis. You will help ensure that all regulatory obligations, including quality control and quality assurance functions, are properly performed. In addition, you will become a member of Natera’s laboratory operations team and help ensure that the Austin laboratory properly deploys and validates CLIA and CAP compliant tests. You will further ensure that the Austin laboratory consistently provides accurate and reliable patient test results and reports.
- Review, approve and sign-out reports for a variety of clinical molecular/cytogenetic results, including NIPT, carrier screening and hereditary cancer panels, all run on NGS platforms.
- Be responsible for CAP, CLIA and New York State DOH audits and submissions for the Austin facility.
- Confer with other Natera lab directors, including curatorial and technologist staff, to review and classify detected genomic variants using ACMG guidelines. Interpret NGS and confirmatory results in the context of medical literature, online variant databases and other references along with relevant patient demographic data.
- Aide Genetic Counselors in the preparation and release of test reports via Natera’s LIMS system.
- Help set quality standards for laboratory operations and acceptable levels of analytic performance to ensure that these are maintained.
- Ensure that QC, QA, and QI practices remain consistent with company policies, state, local and federal regulatory standards and ACMG and other professional practice guidelines.
- Ensure proper proficiency testing and implement relevant corrective actions.
- Develop and/or Review and approve Austin Texas lab SOPs.
- Provide vital clinical oversight for daily operations of the Austin laboratory with continual evaluation and improvement of laboratory strategies and protocols.
- Help evaluate and refine the set of diseases and variants for which company offers services as well as diagnostic and screening reports.
- Work in conjunction with the R&D team to oversee validation of new tests and help manage the transition to clinical testing.