Scientist II / I Process Development (Assay Development)
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.
Summary:
GRAIL is seeking a Scientist II or I to support the process development of the Multi-Cancer Early Detection assay. You will contribute to R&D studies in the Product Development of the In Vitro Diagnostic Device and support continuous process improvement of GRAIL’s groundbreaking laboratory developed test. You will develop assay processes under Design Control to enable the integration of reagent and sample through a high throughput platform using automated workcells. Responsibilities include reagent integration on an automated platform, in-process sample stability, assay guard-banding, development of workflows for sample rerun, and repeat to decrease the product failure rate, and troubleshooting complex problems. The ideal candidate is a curious thinker and passionate problem-solver that possesses experience in developing assay workflow with experience in automated NGS assay.
Your Tasks and Responsibilities will include:
- Apply knowledge of biochemistry and molecular biology to develop robust products with streamlined workflows
- Plan, design, execute and report R&D experiments in collaboration with scientists, engineers, data analyst and biostatistician
- Perform assay characterization to determine critical process parameters and tolerances of the system
- Support process development by participating in requirements gathering, process mapping, and risk assessment to determine reagent formats and sample flow on high throughput automated platform
- Support troubleshooting, root cause analysis, and investigation activities for Quality events such as deviation, incident report, and CAPA
- Support continuous process improvement activities through change control for implementation in Operations.
- Evaluate and present experimental data analysis, methodology, and results at technical meetings as well as document experimental plans and results in reports
Your background and qualifications will include:
- M.S. degree or Ph. D 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 scientist in process development or related occupation in assay integration with automated liquid handlers
- Experience with troubleshooting of NGS assay protocols including library preparation, target enrichment, sequencing with automated liquid handler is a plus
- Experience with the development and implementation of clinical laboratory tests under CAP/CLIA or FDA/regulated environments
- Experience with statistical programming or software (e.g, R, JMP) is a plusAttention 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.