Research Associate, Investigations and Troubleshooting, Technical Operations - RTP

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 Research Associate for the Technical Operations team based in North Carolina (RTP), who will be primarily responsible for ensuring the sustained performance of GRAIL assays in support of production activities. The ideal candidate is a diligent, dynamic teammate with experience in both automated and manual NGS workflow execution. The candidate will be expected to partner across multiple functions of the organization - Automation, Product Development, LIMS, Process Monitoring, Manufacturing Sciences and Technology, Quality Assurance, Supply Chain, Biosample Operations, and the Clinical Laboratory - to ensure the compliant and timely completion of patient testing.
YOU WILL:

• Assist with the timely identification, containment, and documentation of nonconformances
• Assist with the design and execution of experimentation to support technical quality investigations ranging from reagent characterization and evaluation (e.g. pH, conductivity, purity) to the collection and testing of intermediates (e.g. fragment analysis, qPCR quantification, NGS) to identify process issues
• Clearly, accurately, and succinctly record work performed per GxP requirements, including methodology and results
• Communicate effectively and directly with Clinical Lab staff and senior members of Technical Operations to identify and address areas of risk for GxP/ISO/CAP/CLIA processes.
• Act as a Technical Operations SME and work with Quality to resolve and document investigations, troubleshooting of validated processes, and Corrective and Preventive Actions (CAPAs). May lead investigation teams in troubleshooting and root cause analyses, depending upon level.
• Ensure laboratory activities are performed in compliance with procedures and safety guidelines when handling, storing, and disposing of hazardous or bio-hazardous materials.
• Have excellent personal task management skills and a high level of self-motivation.
• Use productivity software (e.g. Jira, Confluence, Smartsheets) to track and report progress on investigation, troubleshooting effort progress
• Approach change with an open mind and a willingness to find solutions
• Contribute to the design and maintenance of data collection processes to track investigation/troubleshooting topics, frequency, etc. to support the identification of process/product improvement and optimization projects.
• Review performance data and specifications related to reagents, methods, and personnel involved in the execution of GRAIL’s commercial assay(s)
• Plan and record studies and investigations performed and recorded in line with regulatory requirements (GxP/ISO/CAP/CLIA)
• Act and present as a Technical Operations SME for reagents, reagent specifications, methods, and processes related to current execution of assays by the Lab Operations team and personnel of GRAIL’s commercial assay(s)
• equipment, equipment performance specifications,
• Promptly gather, analyze, and summarize data to inform nonconformance containment activities

YOUR BACKGROUND AND QUALIFICATIONS WILL INCLUDE:

• B.A, B.S. or M.S. degree in Molecular Biology, Biochemistry, or relevant fields with 2+ years of relevant experience
• Proficient with standard molecular biology laboratory techniques
• Experience identifying and resolving problems with molecular testing methods
• Direct experience with GxP best practices and GDP documentation
• Strong attention to detail, safety, and regulatory compliance
• Strong verbal and written communication skills, demonstrated ability to collaborate effectively with cross-functional teams
• Experience contributing to diverse and interdepartmental project teams
• Effective written and verbal communication skills (fluency in English) as well as strong interpersonal, negotiation, and influencing skills
• Strong technical self-direction and willingness to learn new techniques
• Good planning, prioritization, problem-solving, and organizational skills
• Strong technical writing skills
• General digital literacy and proficiency in GSuite and/or Microsoft Office Suite
• Proficiency with statistical software (JMP, Tableau, SPS, Minitab) preferred
• Experience executing and troubleshooting automated liquid handling workflows and/or automated NGS library preparation strongly 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, 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.