Process Engineer I ( Molecular Biology)

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 I at GRAIL, you will support development projects by contributing to a dynamic Product Development team. The ideal candidate will possess experience developing and executing processes to support a high-throughput NGS-based assay, including evaluating and characterizing equipment and reagents, designing and testing manufacturing processes, and drafting documentation including protocols, reports, and SOPs. Candidates should possess strong troubleshooting skills, experience with GxP systems, and be a great teammate.
You will:

• Validate test methods for new reagents and instruments, including NGS oligos and molecular diagnostics equipment.
• Characterize, and execute new laboratory equipment qualification processes within an NGS setting.
• Participate in the development of product plans, evaluation of processes and process risk, and development of project timelines.
• Manage projects and relationships with critical material suppliers.
• Contribute to the planning, preparation, and execution of experiments to support development of the next generation of GRAIL technology.
• Develop strategies for characterization of automated processes, including determination of critical process parameters, control limits, and SPC rule sets.
• Sustain existing platforms through continuous improvement efforts, failure analysis, and maintenance of supporting documentation.
• Support the transfer and execution of equipment qualification protocols at CMOs.
• Troubleshoot procedures and recommend improvements or alternative procedures if needed.
• Responsible for accurately recording work performed per GLP, including results and methodology.
• Calculate, compile and analyze experimental data.
• Write reports, work instructions, and SOPs for development and transfer activities.
• Present data at technical meetings.

Your background will include

• Demonstrated success in technical proficiency, creativity and collaboration with others. Experience in design and execution of studies for the evaluation and qualification of NGS-related equipment in a regulated environment is desired.
• B.S. in biochemistry, molecular biology, bioengineering, or related fields preferred. M.S. is a plus.
• 2+ years of experience in the medical device or pharmaceutical industry working in process engineering, R&D, or systems engineering.
• Experience with product development including process validation, equipment qualification (IQ/OQ/PQ), tech transfer, and process characterization required.
• Must have excellent personal task management skills and a high level of self-motivation.
• Expertise in molecular biology.
• Experience with Design of Experiment (DOE) methodology.
• Experience with Six Sigma, CIP, Root Cause Analysis techniques.
• Experience with medical device regulatory requirements and ISO quality standards.
• Experience with automated laboratory equipment such as robotic liquid handlers and qPCR instruments.
• 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.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies (“Agency”), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings (“Agreement”).  GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place.  Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement.   Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes.  Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team.