Staff Process Engineer - Tech Transfer

Employer
GRAIL, Inc.
Location
Raleigh-Durham, NC, United States
Posted
Feb 17, 2021
Ref
251315121
Hotbed
Bio NC
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 www.grail.com.

The R&D Tech Transfer group is responsible for delivery of new process- and products- related projects, into GRAIL's Research Triangle Park production facility. As a Sr. Process Engineer you will work with R&D and Operations organizations to ensure smooth communication and implementation of process/product introductions, coordination the execution of validations with appropriate protocols, reports and SOPs, and scoping and guiding continuous improvement projects. The ideal candidate will possess extensive experience delivering manufacturing processes and equipment test methods into operational environments, specifically with applications in high-throughput sample screening, molecular testing, or IVD development in a regulated and highly cross functional environment.

You Will:

• Coordinate the overall pipeline of process / product introduction into operations from R&D
• Define and maintain clearly communication channels for future operational additions
• Understand Operational needs, such that documentation, training, and data can be delivered efficiently and effectively
• Ensure Operations are appropriately represented in gathering requirements for development projects
• 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.
• Lead, execution, and documentation of validation testing across a diverse set of equipment used in various approaches for DNA analysis and NGS workflow.
• Support reagent manufacturing processes, and support internal and external technical transfer projects.
• Assist in troubleshooting, and automated assay and test method optimization, using engineering statistical models and uncertainty analysis.
• Coordinate verification and validation execution activities for process transfer to operations teams and manage internal transfer activities
• Draft plans, reports, work instructions and SOPs for development and transfer activities.
• Identify opportunities for process improvement, focusing on manufacturing and integration, supporting robustness and capacity.
• Drive scoping and risk assessments of continuous improvement projects, tracking project execution across multiple sites / groups.
• Ensure implementation of continuous improvement is done in compliance with change control processes
• 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 material

Your Background Will Include:

• Masters in Life Sciences field with 8+ years of industry experience or Bachelors with 10+ years of industry experience.
• Molecular diagnostics or pharmaceutical industry experience preferred, ideally a practical knowledge of Next Generation Sequencing workflows and applications.
• Demonstrated success in building relationships between Ops and R&D organizations
• Track record of successful delivery of new manufacturing or screening processes to operations
• Experience in molecular IVD product development under Design Control in a regulated environment, including assay verification, integration and testing, transfer to production.
• Experience product transfer and verification/validation in an FDA-regulated environment.
• Experience with the development of instrument and equipment qualification processes.
• Experience with a variety of laboratory equipment and test methods, including liquid handlers and lab automation.
• 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.

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 .