Process Engineer 1/2 - Reagent Development

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
Feb 20, 2021
Ref
566683988
Hotbed
Biotech Bay
Required Education
Bachelors Degree
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 www.grail.com.

As a Process Engineer 1/2 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 experience developing assay methodology and manufacturing processes for application in a high-throughput sample screening, molecular testing or IVD development in a regulated environment. Responsibilities include developing reagent formulation/manufacturing and characterization processes, designing and executing stability studies, and supporting tech transfer with appropriate protocols, reports and SOPs. Candidates should possess strong troubleshooting skills and be a team player.

You Will:

• Support reagent formulation and manufacturing process development, including QC test methods and raw material characterization for internal and external reagent development projects.
• Manage transfer activities for QC and manufacturing to internal teams and external CMOs. Write plans, reports, work instructions and SOPs related to development and transfer activities.
• Execute pilot-scale manufacturing and manage transfer activities for new reagents.
• Participate in investigations and process improvement activities.
• Support automated reagent manufacturing process development.
• Responsible for accurately recording work performed per GLP, including results and methodology.
• Calculate, compile and analyze experimental data.
• Ensure laboratory activities are performed in compliance with procedures and safety guidelines when handling, storing and disposing of hazardous or bio-hazardous materials.
• Write reports, work instructions and SOPs for development and transfer activities.
• Present data at technical meetings.

Your Background Will Include:

• B.S. in biochemistry, molecular biology, or related field with 2+ years related experience, M.S. a plus.
• 2+ years of industry experience with 1 year of product development experience with assay verification, integration and testing, transfer to production and documentation.
• Demonstrated success in technical proficiency, creativity and collaboration with others. Experience in design of studies for the evaluation and qualification of regents in a regulated environment is desired.
• Must have excellent personal task management skills and a high level of self-motivation.
• Experience with molecular biology assays.
• Experience with analytical testing platforms.
• Experience handling cell free DNA samples desired.
• Experience product transfer desired.
• Experience with automation, and LIMS, a plus.
• Experience working with electronic quality management systems, a plus.
• Theoretical and practical knowledge of Next Generation Sequencing sample preparation workflows and applications preferred.
• Excellent verbal and written communication skills and willingness to collaborate cross-functionally.

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.