Natera is hiring a
Senior Scientist

Summary

Join Natera as a Sr. Scientist to be a key member of our R&D IVD Assay Development team, contributing to experimental study design and overseeing documentation, execution, and data analysis of experiments for various development projects for FDA-regulated products.

Requirements

• PhD degree in Molecular Biology, Biochemistry, or related field with 4+ years industry experience in developing NGS based assays from concept to commercialization
• Masters or Bachelors candidates with 6+ years or 8+ years, respectively, may also be considered
• Experience with assay workflow development, optimization required
• Demonstrated experience with standard processes and approaches for IVD verification and validation required
• Experience in IVD development for NGS applications is required
• Knowledge of quality and regulatory requirements (ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971) is highly required
• Experience in preparing technical summaries for regulatory submission (including ex-US) is highly desirable
• Knowledge of DOE and Statistical methods highly desirable
• Solid skills in document writing; development of reports, plans, work instructions, technology transfer from R&D to manufacturing required
• Comfortable in a role of technical leader for a project, willingness to direct and manage project activities for team members as well as function as an individual contributor to the team
• Willing to analyze results from both the perspective of product development and requirements for robust products and the perspective of the customer
• Detail-oriented, organized, ability to plan, design, and oversee execution of protocols
• Analytical, detail oriented, organized, efficient, problem solver
• Must have a desire to be part of a fast-paced and dynamic development environment
• Excellent communication skills, both written and verbal

Responsibilities

• Contribute to experimental study design
• Oversee documentation, execution, and data analysis of experiments
• Prepare technical summaries for submission to regulatory bodies
• Coordinate with matrixed teams on projects throughout design-controlled product development phases
• Own, create, and maintain several design control deliverables
• Assist with external-facing discussions and collaborations with Biopharma partners and regulatory bodies
• Analysis and presentation of complex datasets
• Contribute to the overall success of projects; anticipate problems to minimize issues and work to resolve any issues to mitigate impact on success of project
• Mentor, direct, and assist junior scientific staff setting an example for good scientific practices
• Write experimental reports, summaries, and protocols for supervisors, project needs, and other teams as appropriate
• Assist with strategy, risk management, documentation, and improvement of processes, as applicable

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents
• Free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits