Scientist R&D, Reagent QC

POSITION SUMMARY:

The Scientist R&D, Reagent QC within the Platform group will join a tight-knit and cross-functional team of scientists and engineers who are tasked with developing a scalable and robust platform upon which the next generation of Natera clinical assays will be based. In this role, the Scientist will characterize reagents used in Natera’s products and develop quality control assays and manufacturing processes. Working closely with assay development scientists and automation engineers, the Scientist will evaluate technologies that measure reagent properties and identify criteria used to assess reagent acceptability. We are looking for a meticulous and dedicated candidate with experience in assay development that can work effectively in a fast-paced environment to ensure that the highest quality reagents are used for our patients.

 

PRIMARY RESPONSIBILITIES:

• Design, develop, and validate quality control assays that will be used to test both incoming and manufactured reagents.

• Design, execute, and lead reagent characterization, stability, and tolerance studies.

• Collaborate with automation engineers to improve reliability, increase throughput, and decrease costs of reagent quality control assays.

• Work with Clinical Laboratory and Quality Assurance to ensure that developed methods meet Natera’s rigorous quality standards.

• Document results, author SOPs, and provide training to Operations team members.

• Perform other duties as assigned.

• 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.

• Must maintain a current status on Natera training requirements.

 

QUALIFICATIONS:

• Bachelor’s degree in molecular biology, biochemistry, or closely related field with 3+ years experience in assay development for the life science industry

• Master’s degree in molecular biology, biochemistry, or closely related field with 2+ years experience in assay development for the life science industry.

• Doctorate in molecular biology, biochemistry, or closely related field with 0-2 years experience in assay development for the life science industry.

 

KNOWLEDGE, SKILLS, AND ABILITIES:

• Extensive hands-on experience in NGS assay development, troubleshooting, and root cause investigation. Experience performing stability studies and guard band studies is a plus.

• Strong understanding of the chemistry underlying nucleic acid extraction, PCR, library preparation, and next-generation sequencing.

• Must have experience with various molecular biology techniques including but not limited to: next generation sequencing, PCR/qPCR, and nucleic acid extraction and quantification.

• Must have experience performing data analysis in Excel or similar software.

• Must be able to plan studies, manually execute experiments in the lab, analyze data, and determine next steps.

• Must have good communication, scientific presentation, and time management skills.

• Experience developing reagent manufacturing processes is a plus.

• Experience collaborating cross-functionally with other groups (CLIA, QA, Automation) is a plus.

• Coding proficiency (Python or R) and liquid handler programming experience are a plus.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.San Carlos, CA $108,800—$135,950 USD

OUR OPPORTUNITY

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 gene