Staff Scientist, NGS IVD Assay Development
This position will be working out of our San Carlos, CA or Austin, TX offices or Remote, USA
Natera is looking for a highly talented Staff Scientist to be a key member of our R&D IVD Assay Development team. You will become a technical development leader of an integrated and multidisciplinary team to create new NGS-based clinical oncology assays leveraging Natera’s proprietary technology. Candidates with a proven track record developing NGS assays from concept to regulatory submission to commercialization will be considered. As a successful candidate, you will work in a dynamic, team-oriented environment including molecular assay scientists, biostatisticians, quality assurance, regulatory affairs, bioinformatic scientists and software engineers. The successful candidate will love integrating and leading first-rate science and the best-practice tenets of technical IVD product development with a phenomenal group of scientists and engineers.
- Senior member of the team directing scientists and contributing to experimental study design and overseeing documentation, execution and data analysis of experiments for various development projects for FDA-regulated products (510K, de-novo, CDx).
- Lead 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 the best-in-class development milestones.
- 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.
- 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.
- PhD degree in Molecular Biology, Biochemistry, or related field with 5+ years industry experience in developing NGS based assays from concept to commercialization.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Experience with assay workflow development, optimization required.
- Demonstrated experience with standard processes and approaches for 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.
- Knowledge of DOE or 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.
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.