GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

GRAIL is seeking a Senior Staff Scientist in the Assay Development team at our Menlo Park R&D headquarters to lead development and integration studies for GRAIL’s groundbreaking cancer screening products. As a senior technical lead, you will be responsible for leading sophisticated large-scale wet-lab development studies and investigative workstreams on advanced mutli-system assay technology in support of product development goals, including directing the design, planning, execution, and analysis of studies in collaboration with junior technical staff and biostatistics/bioinformatics teams. The ideal candidate is a technically-rigorous team player with demonstrated experience in automated NGS assay development, genomic data analysis, and outstanding communication and collaboration skills. The ideal candidate has developed and successfully completed FDA approval for IVD product(s).

You will...

• Technical lead on studies in support of the development and integration of automated NGS assays used in clinical laboratory products in a regulated environment
• Drive development efforts to optimize and characterize assay performance, streamline laboratory workflows, finalize specifications, and ensure production robustness
• Lead design and documentation of formal study protocols and technical reports to arrive at specifications in support of product DHF
• Lead laboratory experimentation in collaboration with junior technical staff to generate high quality data by following best practices of assay and instrument operations
• Collaborate closely with biostatistics and bioinformatics functions to develop robust study designs, plan experiments, and generate comprehensive data analyses
• Collaborate closely with other assay, automation, reagents, software, and operations team members to optimize functionality of novel complex automated NGS assays
• Conduct troubleshooting investigations and related experimentation to address acute or systematic issues with implemented systems
• Evaluate and present experimental data analysis, methodology, and results at technical meetings
• Work with Quality and Regulatory team members to ensure studies fulfill necessary guidelines and regulations (CAP/CLIA/FDA)
• Summarize, present and document study outcomes to key stakeholders and for submission to FDA
• Supervise and train scientists and research associates

Your background should include...

• PhD in Molecular Biology or Biochemistry with 5+ years of experience in Life Sciences or Diagnostics industry
• Experience designing experiments to optimize and characterize assay performance and set specifications
• Success in leading and develop 2-3 junior technical staff (RAs, junior scientists)
• Strong experience with and in-depth knowledge of Illumina NGS
• Experience developing successful IVD products under design control preferred

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine and “Up to Date” with any recommended booster. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered; "Up to Date" means having timely received any COVID-19 vaccine booster(s) in accordance with CDC guidelines. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.