Manager of Statistical Programming

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

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

Natera is seeking a Staff Scientist to join our Early Research Team. The primary focus of this role is to independently lead the research and development of novel next-generation sequencing (NGS) technologies. In this role, you will lead projects from ideation to prototype, specifically designing and optimizing high-complexity NGS methods to advance our oncology diagnostic portfolio. Success in this role requires a deep technical foundation in molecular biology and NGS plus a proven track record of industrial R&D leadership. Primary Responsibilities: Lead and manage the development of innovative NGS-based diagnostic assays from feasibility through optimization. Define project goals and plans with input from stakeholders and manage multiple project streams in parallel. Independently design and execute complex laboratory experiments; analyze and interpret results to guide research direction. Coordinate cross-functional efforts to meet milestones and collaborate closely with bioinformatics, statistics, and data science teams to ensure robust experimental design and data analysis. Mentor and guide junior scientists while promoting scientific rigor and best practices. Author high-quality protocols, technical reports, and study documentation. Communicate progress regularly to stakeholders, including departmental meetings and senior leadership. Contribute to risk management, strategy development, and continuous improvement of scientific workflows. Qualifications: Ph.D. in molecular biology, genomics, or a closely related field. Minimum 8 years of relevant industry experience, or 2+ years postdoctoral research with 6+ years in industry. Proven experience in designing and advancing NGS-based diagnostics, preferably in the field of oncology. Required Expertise: A strong technical foundation in molecular biology or chemistry. Deep mechanistic knowledge of NGS library preparation chemistry. Demonstrated ability to independently design and execute complex experiments (solid

POSITION SUMMARY: Manager, QC Development is responsible for modifying existing methods and/or developing and optimizing new QC methods to support routine lot release of reagents and kits used in the CLIA laboratory. Provides technical and scientific operations support in event of deviations and/or non-conformance issues arising for reagent preparation and/or qualification. PRIMARY RESPONSIBILITIES: Primary responsibilities include leading a team responsible for development and optimization of reagent Quality Control (QC) Tests and associated bio-chemical process optimizations to support routine reagent and kit qualification. Analyze data and prepare documentation for QC method validation, author and revise QC testing SOPs and reports to ensure the successful implementation of assays in the laboratory. Oversee technical transfer of new product QC methods from Research and Development into Operations, addressing process development needs for implementation. Provide technical and scientific operations support in event of deviations and/or non-conformance issues arising for reagent preparation and/or qualification to ensure disposition(s) for impacted material(s) are driven by scientifically rational input. Personnel management includes: provide technical assistance, employee development, coaching and counseling, administering performance appraisals, and enforcing company policies through appropriate disciplinary measures QUALIFICATIONS: Ph.D. in Molecular Biology, related field, or equivalent. Minimum of 4 years of experience in Industry. Previous management experience required. Previous experience working in Assay Development or QC lab is highly desired. CLIA/FDA laboratory support experience is a plus. KNOWLEDGE, SKILLS, AND ABILITIES: Leadership and functional management experience of medium sized group. Ability to prioritize responsibilities in a high pace environment. Strong technical expert

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

POSITION SUMMARY: Join Natera’s Oncology Research Use Only (RUO) team as the Laboratory Manager . You will take ownership of the physical operations, asset management, and Environmental Health and Safety (EH&S) compliance for a high-throughput Next-Generation Sequencing (NGS) research laboratory. This environment supports internal and externally contracted research studies rather than clinical diagnostic reporting. You will operate with pace and rigor, using data to anticipate bottlenecks and treating lab compliance as the foundation of execution. PRIMARY RESPONSIBILITIES: Lab Organization & Cleanliness Maintain a clean, safe, and well-organized laboratory that meets institutional and company standards Establish and enforce workspace organization standards, including bench layouts, labeling conventions, shared-equipment zones, and waste segregation Own housekeeping schedules, decontamination routines, and general lab organization, coordinating cleaning and biohazard or chemical waste pickup Ensure adequate stocking and organization of consumables at the point of use Serve as the point of contact for lab safety, ensuring Personal Protective Equipment (PPE) availability, spill readiness, and adherence to EH&S requirements Cross-Team Coordination & Equipment Think team by partnering directly with Facilities, Engineering/Instrumentation, EH&S, Procurement, and IT to drive lab operations without needing translation layers Coordinate preventive maintenance, calibration, service visits, and repair of major instrumentation (e.g., NGS sequencers, liquid handlers, qPCR/dPCR systems, centrifuges, thermal cyclers), minimizing downtime Manage vendor and service-provider relationships, including scheduling, tracking service tickets, and escalating unresolved issues based on data Own end-to-end inventory management, tracking reorder points, purchasing requests, receiving, and stock rotation for reagents, consumables, and controls Maintenance Logs & Protocol