Director of Operations, Data Analytics for Production Support, Extended-Hours

POSITION SUMMARY: The Senior Director, Laboratory Operations is responsible for the management and oversight of all aspects of operations in order to provide the highest quality service including: clinical laboratory and laboratory operations. Knowledge of CAP, CLIA, California, and New York state regulations. PRIMARY RESPONSIBILITIES: Develop policies, procedures, and performance standards to ensure efficiency and quality. Ensure efficient and customer-friendly service. Oversee all clinical and technical functions of laboratory, which includes: day-to-day production, equipment and reagent qualification, and training. Lead trouble-shooting teams to address urgent issues. Ensure that operations maintain all personnel, equipment and consumable resources necessary to match the demand and projections. Maintain and expand laboratory infrastructure, including personnel, equipment, and inventory. Ensure efficient and effective use of resources and personnel within laboratory. Lead process improvements throughout the laboratory. Operationalize and implement new product launches. Maintain the resources required for effective turnaround times for all patient testing. Organize training and development programs for laboratory and support staff. Work with senior leadership to execute on short and long-term strategy. Recruit, retain, train, and develop employees and conduct performance management activities. Develop a team-oriented culture within and between departments. This role works with PHI on a regular basis both in paper and electronic form and have 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 Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire. Must maintain a current status on Natera training requirements. QUALIFICATIONS: BS/BA (or equivalent) in a biological scien

POSITION SUMMARY: Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support. Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions. You will serve as the technical subject matter expert in FDA interactions, partnering across functions to deliver design-controlled diagnostic products that directly impact patient care. PRIMARY RESPONSIBILITIES: Own the execution of the technical strategy and phase-gated process of of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and research teams Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and go/no-go recommendations at phase gates Deliver the analytical performance data package supporting Class III PMA submissions, developing a comprehensive approval strategy with RA Serve as t

This is an exciting opportunity to lead and grow the Data Science and Bioinformatics function supporting Natera's Women's Health and Organ Health product portfolios. In this role, you will build the bioinformatics capability within the Data Science development team, establish scalable AWS cloud infrastructure, and ensure the quality and reproducibility of the genomic algorithms powering our clinical products. PRIMARY RESPONSIBILITIES: Strategy and Vision Build and define the Bioinformatics function within the Data Science development team, identify technical tooling gaps, and execute a roadmap to advance genomics-based algorithm development. Establish and enforce pipeline and algorithm quality standards, including review processes, validation frameworks, and documentation practices Infrastructure and Automation Own and architect scalable AWS-based data science and bioinformatics infrastructure, ensuring quality, reproducibility, and reliable deployment of Next-Generation Sequencing (NGS) algorithms. Implement MLOps tooling and automated validation frameworks to support reliable algorithm deployment into clinical production. Cross-Functional Collaboration Partner with Research, Product Development, Laboratory Operations, Engineering, and Quality teams to implement stable, scalable pipelines and support successful productization Team Leadership Lead, mentor and hire a high-performing team of bioinformaticians and data scientists, establishing technical quality standards and clear operational ownership. Build technical depth within the team to support expanding product roadmaps across Women's Health and Organ Health. QUALIFICATIONS: Master of Science or Ph.D. in a quantitative technical discipline (Biostatistics, Bioinformatics, Computer Science, Physics, Applied Mathematics, or equivalent). Minimum of 10 years of experience in Data Science or Bioinformatics, with at least 5 years of direct people management experience leading technical teams. Hands-on experience archi

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

Associate/Laboratory Director of Oncology, Comprehensive Genomic Profiling Position Summary As an Associate Lab Director or Lab Director of Oncology, you have clinical oversight of Natera’s laboratory testing related to cancer 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. You are responsible for ensuring the test validation and development meets all required regulatory standards. This position will be primarily responsible for technical and clinical performance of Natera’s comprehensive genomic profiling (CGP) assays. Title and scope of responsibility will be commensurate with the candidate’s experience. This position is on-site at Natera’s San Carlos, CA Laboratory. Primary Responsibilities Provide clinical sign-out and interpretation for CGP reports, identifying actionable biomarkers and relevant clinical trials Provide technical and clinical support for laboratory staff, genetic counselors, and other clinical personnel Ensure acceptable levels of analytical performance for CGP assays, compliance with applicable standards, and laboratory inspection-readiness at all times Troubleshoot workflow and laboratory issues with clinical care and regulatory standards in mind Document findings and maintain accurate records consistent with Natera policies and procedures May serve as Clinical Consultant . A 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 Qualifications Education: MD/DO and/or PhD in genetics or related field required. Board Certification: ABMGG board-certified in Clinical Cytogenet

POSITION SUMMARY: Join Natera as the Senior Director of Development for our Early Cancer Detection (ECD) and Multi-Cancer Early Detection (MCED) portfolio. You will take ownership of product development strategy and execution, guiding Next-Generation Sequencing (NGS) and cell-free DNA-based (cfDNA) In Vitro Diagnostic (IVD) products from feasibility through FDA Premarket Approval (PMA) and post-market support. Every test represents a real person, and you will build an organization of scientific contributors and managers to deliver robust clinical tools. You will establish priorities, allocate resources, and represent development with the FDA and executive leadership, ensuring that scientific rigor and data drive all regulatory and portfolio decisions. PRIMARY RESPONSIBILITIES: Define and own the multi-year assay development strategy and technical lifecycle for the ECD and MCED portfolio, in alignment with corporate and R&D strategy Take accountability for the phase-gated execution of all ECD and MCED programs, overseeing the development, design verification, and validation of NGS-based cancer detection IVD devices using cfDNA, methylation and other analyte classes. Set team priorities, allocate people, budget, and laboratory resources, and make or recommend go/no-go decisions to executive leadership Establish the analytical verification and validation strategy for the portfolio to ensure robust assays transfer seamlessly to commercial manufacturing Partner with clinical, medical, and biostatistics leaders to support approvable pivotal and prospective study design, statistical analysis plans, and performance claims for screening-population use in both the ECD and MCED intended-use claims Define regulatory pathways and evidence requirements for PMA submissions for ECD and MCED in an evolving regulatory landscape. Be facile in representing the Development approach and activities in senior-level engagement with the FDA (e.g., pre-submission meetings and advisory pan