Remote Senior Scientist

Summary

Join Natera as a Sr. Scientist in our R&D IVD Assay Development team, contributing to experimental study design and overseeing documentation, execution, and data analysis of experiments 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

Responsibilities

• Contribute to experimental study design and oversee documentation, execution and data analysis of experiments for various development projects for FDA-regulated products (510K, de-novo, CDx)
• Accountable for preparing technical summaries for submission to regulatory bodies, such as the FDA, PMDA, IVDR, etc
• Closely coordinate with matrixed teams on projects throughout design-controlled product development phases, contribute to core teams, and work with cross-functional leads from Product and Program Management to deliver development milestones for best-in-class IVD products
• Responsible for owning, creating and maintaining several design control deliverables such as Design Inputs/Outputs, Trace Matrix, FMEAs, development and design verification and validation study plans, stability plans, among others, as applicable
• Assist with external-facing discussions and collaborations with Biopharma partners and regulatory bodies
• Analysis and presentation of complex datasets with the support of bioinformatic scientists
• 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