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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com
As a Sr. Process Engineer at GRAIL you will support development, engineering, and transfer projects by contributing to an evolving, dynamic product development and sustaining team. The ideal candidate will possess extensive experience developing manufacturing processes and equipment test methods for application in high-throughput sample screening, molecular testing or IVD development in a regulated and highly cross functional environment. Responsibilities include identifying and implementing manufacturing improvements, development of instrument or system performance characterization and qualification protocols, and executing validation plans with appropriate protocols, reports and SOPs. Candidates should possess strong troubleshooting skills and be a team player.
- Develop/implement laboratory test processes necessary to enable high-throughput sample screening though next generation sequencing assays.
- Lead planning, preparation, execution, and documentation for qualification of a diverse set of equipment used in various approaches for DNA analysis and NGS workflow.
- Implement IQ/OQ/PQ strategy for instruments, including processes for requalification and preventative maintenance on a broad range of instrumentation including liquid handlers, mixers, incubators, thermocyclers, plate readers, etc.
- Support reagent manufacturing processes, and support internal and external technical transfer projects.
- Troubleshoot and optimize automated assays and test methods.
- Experience with engineering statistical models and uncertainty analysis.
- Lead verification activities for process transfer to operations teams and manage internal transfer activities. Write plans, reports, work instructions and SOPs for development and transfer activities.
- Participate in project planning as part of a cross-functional team.
- Identify opportunities for process improvement, focusing on manufacturing and integration, supporting robustness and capacity.
- Support manufacturing processes, including QC test methods and raw material characterization.
- Evaluate and present experimental data analysis, methodology, and results at technical meetings.
- Ensure laboratory activities are performed in compliance with procedures and safety guidelines when handling, storing and disposing of hazardous or biohazardous materials.
Your Background Will Include:
- Demonstrated success in developing technical proficiency, problem solving creativity and collaboration with others. Experience in IVD Design, Design Control or assay development in a regulated environment is desired.
- PhD in biochemistry, molecular biology, or related field preferred with 6+ years of industry experience or BS/MS with 8+ years of industry experience.
- Molecular diagnostics or pharmaceutical industry experience preferred.
- Experience in molecular IVD product development under Design Control, including assay verification, integration and testing, transfer to production.
- Expertise in the development of instrument and equipment qualification processes.
- Experience with a variety of laboratory equipment and test methods, including liquid handlers and lab automation.
- Experience with nucleic acid extraction technologies, best practices for DNA handling and analytical testing platforms.
- Experience product transfer and verification in an FDA-regulated environment desired.
- Practical knowledge of Next Generation Sequencing sample preparation workflows and applications preferred.
- Excellent personal task management skills and a high level of self-motivation.
- Excellent verbal and written communication skills and willingness to collaborate cross-functionally across Quality, Regulatory, Operations and Development teams.
- Must have excellent personal task management skills and a high level of self-motivation.
- Experience with analytical testing platforms.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.