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.

As a Senior Process Development Engineer at GRAIL you will support the development of the Multi-Cancer Early Detection platform by contributing to an evolving and dynamic R&D product development team. You will develop processes and workflows that manipulate cell-free DNA with molecular biology techniques and automation to produce sequenceable molecules. Responsibilities include the development of sample, intermediate, consumable and reagent flows and the characterization of system, sub-systems and processes. The ideal candidate is a curious thinker and passionate problem-solver that possess experience in developing assay methodology and manufacturing processes for application in a high-throughput sample screening, molecular testing or IVD development in a regulated environment.

You Will:

• Develop robust process flow and inflection points of the system in collaboration with scientists and engineers by designing and executing R&D experiments to characterize critical quality attributes and critical process parameters
• Develop, integrate and test sub-systems for materials flow by supporting requirements gathering, process mapping, and risk assessment to determine reagent formats and process intermediates
• Support the root cause investigation and improvement of sub-system performance issues related to integration of the Next-Generation Sequencing assay and high throughput instrumentation
• Evaluate and present experimental data analysis, methodology, and results at technical meetings as well as document experimental plan and result in reports 
• Ensure technical activities are in line with regulatory requirements (CAP/CLIA/FDA)

Your Background Will Include:

• B.S. or M.S. degree in Molecular Biology, Biochemistry, or relevant disciplines with a minimum of 5+ years of work experience in an industry setting
• Previous experience as a hands-on process engineer, system integration engineer or related occupation in process development
• Hands-on experience with molecular biology techniques, assay development or process development in particular on automated systems
• Experience with root cause analysis methodology is a plus
• Experience with troubleshooting of NGS assay protocols including library preparation, target enrichment, and sequencing is a plus
• Experience with the development and implementation of clinical laboratory tests under CAP/CLIA or FDA/regulated environments including document, design or change controls
• Experience with statistical programming or software (e.g, R, JMP) a plus
• Attention to detail, safety, good laboratory practice, and good documentation practiceStrong 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.