Staff Scientist - Assay V&V

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Job description

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 .

GRAIL is seeking a Staff Scientist in the Assay Implementation (Verification & Validation) team at our new RTP production facility to perform integration and testing of GRAIL's groundbreaking cancer screening products! You will be responsible for leading wet-lab late stage research and development studies in support of product development goals, including the design, planning, execution, and analysis of complex experiments. We are seeking a technically-rigorous individual with strong experience in automated NGS assay development, genomic data analysis, and outstanding communication skills. The ideal candidate has developed and successfully completed FDA approval for IVD product(s).

You Will:

• Act as the Technical lead on studies in support of the integration, verification, and validation of automated NGS assays used in clinical laboratory products in a regulated environment
• Collaborate closely with other assay, automation, software, and operations team members to integrate and functionalize novel complex automated assays
• Drive development efforts to optimize assay performance, improve laboratory processes, and ensure production robustness
• Conduct troubleshooting investigations and related experimentation to address acute or systematic issues with implemented systems
• Collaborate closely with biostatistics and bioinformatics functions to develop robust study designs and comprehensive analyses
• Work with Quality and Regulatory team members to ensure studies fulfill necessary guidelines and regulations (CAP/CLIA/FDA)
• Develop experimental plans that support PMA study objectives
• Execute laboratory experiments in collaboration with more junior technical staff to generate high quality data by following best practices of assay and instrument operations
• Perform data analysis and document study outcomes and conclusions
• Summarize, present and document study outcomes to key stakeholders and for submission to FDA
• Present and defend study designs and results to FDA inspectors in pre-market audit.
• Support training of junior Research Associates
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Your Background Will Include:

• PhD degree in Molecular Biology, Genetics, Cancer Genomics or relevant fields with 8 years of postdoctoral or industry experience.
• Strong hands-on laboratory experience and in-depth knowledge of Illumina NGS workflows including nucleic acid extraction, library preparation, target enrichment, and sequencing.
• Hands-on experience with automated laboratory instrumentation such as liquid handlers and multi-functional workcells
• Experience with the development, optimization, and troubleshooting of NGS assay protocols a plus, in particular on automated systems
• Experience with the development and implementation of clinical laboratory tests under CAP/CLIA or FDA/regulated environments
• Experience with design control and change control.
• Experienced with standard nucleic acid analytical techniques (e.g, qPCR, Nanodrop, Fragment Analyzer, ddPCR)
• Experience with statistical programming or software (e.g, R, JMP)
• Experience with Design of Experiment (DOE) a plus
• Attention to detail, safety, good laboratory practice, and good documentation practice
• Strong verbal and written communication skills and willingness to collaborate cross-functionally in a fast-paced and dynamic environment

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, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. 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.