IVD Product Development Scientist

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POST DATE 9/17/2016
END DATE 10/18/2016

Natera San Carlos, CA

Company
Natera
Job Classification
Full Time
Company Ref #
361006
AJE Ref #
576206199
Location
San Carlos, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.

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.

Natera is seeking a highly motivated Senior IVD Product Development Scientist to join the R&D group. Natera's expert research & development team is making rapid advances in applying cutting edge molecular biology,next-generation sequencing,and advanced statistics to the fields of fertility,maternal-fetal medicine, and oncology.Demonstrating the value of our tests in clinical trials and ensuring test performance for regulatory approval is essential to Natera's reputation and integrity. The new team member will participate in Natera s R&D activities to develop new tests for prenatal care for use in Natera s clinical laboratory and other regulated markets.

PRIMARY RESPONSIBILITIES:
Plan, execute, analyze, and document IVD product development activities with superb attention to detail under a design control system.
Ensure product performance by employing proven development practices optimization, guardband testing, gauge R&R, stability testing, LOQ testing, etc, following CLSI and FDA recommended guidelines.
Make fundamental scientific contributions toward producing robust products.
Develop and implement quality control procedures for critical reagents and processes.
Perform data analysis with advanced analytical and statistical tools (JMP, Excel).
Keep a detailed laboratory notebook and summarize work in research reports and laboratory meeting presentations.
Communicate results with colleagues and R&D management.
Supervise the activities of direct reports or team members at the junior level.