Senior/Staff Process Engineer - Reagent Development

Menlo Park, CA, United States
Feb 14, 2021
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
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

As a Senior/Staff Process Engineer at GRAIL you will support assay development, engineering, and research projects by contributing to an evolving, dynamic product development team. The ideal candidate will possess extensive experience developing test methodology and manufacturing processes for application in high-throughput sample screening, molecular testing or IVD development in a regulated environment. Responsibilities include researching and recommending manufacturing improvements, developing reagent formulation, manufacturing, and characterization processes, and executing validation plans with appropriate protocols, reports and SOPs. Candidates should possess strong troubleshooting skills and be a team player.

You Will:

• Lead the development and evaluation of technologies for process improvement, focusing on manufacturing and integration, supporting robustness and capacity.
• Develop reagent formulation and manufacturing processes, including QC test methods and raw material characterization for internal and external reagent development projects.
• Troubleshoot and optimize automated manufacturing methods.
• Lead planning, preparation, execution, and documentation of projects focused on the development of reagents and test methods used in diverse approaches for DNA analysis.
• Support transfer activities of QC and manufacturing to internal teams and external CMOs.
• Write plans, reports, work instructions and SOPs related to development and transfer.
• Provide technical leadership to project teams performing development work per GLP and transition through the Design Control process.
• Evaluate and present experimental data analysis, methodology, and results at technical meetings.
• Participate in project planning as part of a cross-functional team.
• 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:

• MS in biochemistry, molecular biology, or related field preferred with 3+ years of industry experience. Molecular diagnostics or pharmaceutical industry experience preferred.
• BS with 5+ years of industry experience in product development, including assay verification, integration and testing, transfer to production and documentation in a regulated environment will be considered.
• 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.Must have excellent personal task management skills and a high level of self-motivation.
• Expertise in molecular biology.
• Expertise with IVD development and Design Control.
• Experience with nucleic acid extraction technologies.
• Experience with analytical testing platforms.
• Experience handling DNA samples desired.
• Experience product transfer and verification in an FDA regulated environment desired.
• Experience with liquid handling and automation a plus.
• Practical knowledge of Next Generation Sequencing sample preparation workflows and applications preferred.
• Excellent verbal and written communication skills and willingness to collaborate cross-functionally across Quality, Regulatory, Operations and Development teams.

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.