Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.
Highly motivated Senior Product Development Scientist to join the R&D group. The new team member will participate in Natera's R&D activities to develop new tests for monitoring organ health for use in Natera's clinical laboratory and other regulated markets.
- 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 work tracking 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.
- 4 years of prior experience in a product development role.
- Track record of developing diagnostic tests or reagent kits in a regulated environment; knowledge of design control systems.
- Experience assembling 510(k) and/or PMA documentation is a plus.
- Provide a list of technical or behavioral knowledge, skills, and/or abilities.
- Technical: Evaluates an applicant's acquired knowledge and specific technical skills.
- Behavioral: Evaluates factors related to human characteristics and skills, such as attitude, work approach and collaborative abilities.
- Mastery of NGS-based assay development. Hands on experience with Next Generation Sequencing on Illumina platforms.
- Mastery of qPCR/multiplex PCR - primer design, master mix formulation, protocol optimization; fundamental expertise in nucleic acid quantitation and fragment analysis.
- Experience in organ health testing, or cell free DNA technologies.
- Very strong analytical and problem-solving skills; organized and efficient.
- Proven interpersonal, communication, and presentation skills; excellent time management skills.
- Superb attention to detail; produces work of exceptional quality and accuracy.
- Ability to thrive in a fast-paced, evolving environment; able to manage competing priorities.
- Ability to proactively identify issues and address with solutions-oriented approach.
Duties are typically performed in an office and laboratory setting. This position requires the ability to use a computer keyboard, communicate over the telephone, and read printed material. Laboratory activities require periods of standing while working and occasionally lifting heavy objects. Duties may require working outside normal working hours (evenings and weekends) at times.
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.
WHAT WE OFFER
Competitive Benefits. Generous Employee Referral program. Healthy catered lunches everyday, and premium snacks! Additionally, we offer complimentary premium coffee drinks and teas, and other beverages.
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.