Supervisor, Clinical Lab Scientist

POSITION SUMMARY: The Clinical Laboratory Scientist analyzes specimens and maintains equipment in good operating condition. PRIMARY RESPONSIBILITIES: • Verify the proper specimen being analyzed and perform tests that need to be completed • Analyze clinical laboratory specimens following the standard methods and procedures in an efficient manner with little to no errors • Responsible for maintaining updated understanding and knowledge of methods performed in the lab • Follows GLP (good laboratory practice): maintain clean and organized work space • Completes training and other deadlines on time. • Go-to person when lead/supervisor is not available • Train on specialized instructions for instruments/protocols (super users) • Recognizes and escalates equipment malfunctions; troubleshoots common errors • Recognizes, documents, and escalates protocol deviations in lab to lead/supervisor • Participates in the updating of departmental standard operating procedures and database to accurately reflect the current practices. • Ensures compliance with all regulatory agency requirements through proper documentation • Performs quality control procedures to ensure accuracy of clinical data (if applicable) • Maintains equipment and instruments in good operating condition • Communicates with team and other departments (including via e-mail) • &nb

POSITION SUMMARY Works closely with Senior Manager to ensure company, department, and team goals are met. PRIMARY RESPONSIBILITIES • Monitors workflow and ensures production goals and deadlines are met (e.g. TAT, SLA) • Engages in future planning and scales employees and equipment appropriately • Gathers and monitors metrics on production deadlines, efficiency, scrap waste, and error rates • Monitors the quality control/assurance programs, test results, and equipment (if applicable) • Uses metrics in decision-making and to drive changes across the team (e.g. cost reduction, quality improvement) • Manages sufficient headcount levels to meet production goals by proactively driving the interview process and managing employee PTO and overtime when necessary. • Refines current lab process through continuous improvement projects. • Oversees team specific lab operation. • Go-to person when senior manager is not present; go-to person for knowledge of process and product. • Responsible for seamless transition of automation and test improvement/additions into production workflow • Analyzes and troubleshoots lab processing errors; provides recommendations on how to proceed to lab director, scientists and statisticians as necessary • Supports Supervisors in close out of NCRs. • Responsible for the initiation and close out of CAPAs in a timely manner. • Ensures departmental lab compliance for regulatory bodies • Ensures tests are being completed according to approved procedures. • Maintains an organized, safe and efficient work area for the team at all times. • Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support. • Handles employee issues: complaints, disciplinary actions, etc. Collaborates with Senior Manager and/or Human Resources to resolve issues. • Explains (as much as possible) reasoning behind instructions/processes given/changes that are made. If necessary, explains to team why certain ideas cannot be implem

As the Associate/Laboratory Director, 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 rare disease 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 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 signific

As the Associate/Laboratory Director, Oncology 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 the Signatera MRD assay and other Next Generation Sequencing based assays. Oversee the review of genetic and CNV variant data: interpret NGS 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 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

POSITION SUMMARY: Join Natera’s Oncology Research Use Only (RUO) team as a Supervisor for the Signatera Plasma Team. You will direct laboratory staff executing cell-free DNA (cfDNA) extraction, library preparation, and Next-Generation Sequencing (NGS) workflows to advance our personalized Minimal Residual Disease (MRD) assays. Every sample represents a real person, and you will ensure that all lab processes operate with the pace and precision required to support our clinical pipeline. PRIMARY RESPONSIBILITIES: Oversee the daily scheduling of employees executing DNA extractions, library preparation, Nucleic Acid Quality Control (QC), and NGS workflows Conduct regular 1:1 meetings to deliver unvarnished, data-backed performance evaluations and guide career development Take ownership of daily lab operations by directly executing sample processing alongside the team to maintain throughput Serve as the primary technical point of contact, using data to guide team members on data interpretation, next steps, and troubleshooting Execute process development and method/instrument testing to increase operational precision and scale Use data to identify lab process deviations, root-cause the underlying issues, and document findings via nonconformance reports to drive corrective action Draft, generate, and rigorously review Standard Operating Procedures (SOPs) and work instructions Maintain precise records of lab work using Google Sheets, Microsoft Excel, and internal Laboratory Information Management Systems (LIMS) Ensure accurate, ethical, and appropriate management of samples in strict compliance with all applicable federal regulations Think team by partnering directly with Oncology RUO peer groups to eliminate bottlenecks and optimize sample processing without needing translation layers Present data-backed summaries on team activities, project milestones, and timeline adherence Adapt to evolving science and operational needs, taking ownership of tasks that move th

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY RESPONSIBILITIES: Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.) Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities. Documentation and Reporting : Prepare comprehensive statistical analysis protocols (SAPs), reports, and presentations for cross-functional and external collaborators and stakeholders. Cross-Functional Leadership : Serve as the statistical lead on high-priority project teams. Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches to support diagnostic product development and regulatory submissions Mentor and provide technical supervision to junior team members QUALIFICATIONS: Education : Ph.D. or Master's degree in Biostatistics, Statistics, or a related field Experience : At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology,