POSITION LOCATION:
This position will be working out of our San Carlos, CA or Austin, TX offices or Remote, USA
POSITION SUMMARY:
Natera is looking for a highly talented Sr. Scientist to be a key member of our R&D IVD Assay Development team. 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.
PRIMARY 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.
QUALIFICATIONS:
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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.
KNOWLEDGE, SKILLS, AND ABILITIES:
- 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.