Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.
The Product Development Scientist will plan, execute, analyze, and document verification and validation (V&V) studies, under design control, for next generation sequencing (NGS) assays. Contributes to technical reports to support regulatory submissions. The successful candidate will work closely within the development team as well as collaborate cross-functionally with members of biodevelopment, scientific operations, bioinformatics, quality, regulatory affairs and clinical affairs. The Scientist is expected to divide time between working in the lab and at the desk and providing guidance and training junior team members in their execution of NGS experiments to support in vitro diagnostic (IVD) development. The candidate will maintain a broad knowledge of state-of-the-art principles and theories. The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi-tasking and most importantly, has an interest in our company and our products.
- Design and execute V&V experiments and analyze data for NGS applications in oncology diagnostics utilizing Natera's quality system under design control.
- Independently lead and manage in-lab efforts to design and execute moderate to high complexity experiments with onsite CLIA laboratory, CDx operations team, and other functional groups.
- Coordinates the execution and analysis of V&V experiments with biostatistics and bioinformatics teams.
- Author associated documentation, study protocols and technical reports to support FDA submissions.
- Appropriately documents experimental procedures and results according to established guidelines (ISO/CLSI/etc).
- Ensure that the product meets design requirements, such as design input and output, V&V, etc.
- Supervise junior scientists and team members in their experimental execution and technical documentation.
- Participates in project planning and updates.
- Assist in executing project plans; participates in defining project goals; develops timelines; and contributes to resource requirements.
- Performs data analysis (e.g. R, JMP, Excel).
- Support risk management activities (such as hazard analysis, FMEA).
- Communicates progress directly with colleagues and senior management.
- B.S. with a minimum of 8 years of industry experience, M.S with a minimum of 5 years of industry experience, or Ph.D. with a minimum of 2 years of industry experience.
- Strong scientific background in molecular and cell biology, experienced in cell-based technologies and bio-analytical assay development.
- Knowledge of assay development and/or product development in an industry setting.
- Demonstrated experience supervising scientific staff, coordinating interdepartmental efforts, generating research hypotheses, analyzing complex problems and data, and bringing products to market.
- Strong interpersonal and communication skills.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Skilled at writing clear protocols, reports, and SOPs.
- Hands-on experience with NGS and DNA/RNA molecular biology, preferred.
- Experience with nucleic acid technologies relating to PCR, qPCR, multiplex PCR, digital PCR, NGS and microarrays.
- Experience working under design control, authoring study plans, protocols and study reports is highly desired.
- IVD product development experience with knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA) is desired.
- Track record of contributions towards originating, developing and productizing novel nucleic acid techniques and tests.
- Strong research and product development skills with a history of innovation.
- Experience developing tests in oncology or liquid biopsy is a plus.
- Knowledge of statistical methods and techniques to contribute to analytical studies is desired.
- Ability to follow and establish SOPs and general knowledge of GLP/GMP guidelines.
- Proven success in collaborative and individual projects.
- Ability to work in a fast-paced collaborative team environment.
- Demonstrated success in applying independent scientific judgment in experimental design and analysis.
- Very strong analytical and problem-solving skills.
- Adept with Excel and basic statistical analysis.
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
- Employee must maintain a current status on Natera training requirements.
- Employee must pass a post offer criminal background check.
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.