Updated 30+ days ago

Process Development Engineer II (Assay Dev. Team)

Menlo Park, CA 94025
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$14.55 - $23.66
Full-time, Part-time

Process Development Engineer II (Assay Dev. Team)

Menlo Park, CA /

Research & Development /


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 Development Engineer II at GRAIL you will support the development of the Multi-Cancer Early Detection platform by contributing to an evolving and dynamic R&D product development team. You will develop processes and workflows that manipulate cell-free DNA with molecular biology techniques and automation to produce sequenceable molecules. Responsibilities include the development of sample, intermediate, consumable and reagent flows and the characterization of system, sub-systems and processes. The ideal candidate is a curious thinker and passionate problem-solver that possess experience in developing assay methodology and manufacturing processes for application in a high-throughput sample screening, molecular testing or IVD development in a regulated environment.  

You Will:

    • Plan, execute and analyze R&D experiments in collaboration with senior scientists and senior engineers to understand critical quality attributes and critical process parameters for the development of process flow and inflection points of the system.
    • Develop, integrate and test sub-systems for materials flow by supporting requirements gathering, process mapping, and risk assessment to determine reagent formats and process intermediates.
    • Support the root cause investigation and improvement of sub-system performance issues related to integration of the Next-Generation Sequencing assay and high throughput instrumentation
    • Evaluate and present experimental data analysis, methodology, and results at technical meetings as well as document experimental plan and result in reports.
    •  Ensure technical activities are in line with regulatory requirements (CAP/CLIA/FDA)

Your Background Will Include:

    • Previous experience as a hands-on process engineer, research associate, associate scientist, or system integration scientist / engineer or related occupation
    • B.S. or M.S. degree in Molecular Biology, Biochemistry, or relevant disciplines with a minimum of 3+ years of work experience in an industry setting
    • Hands-on experience with molecular biology techniques, assay development or process development in particular on automated systems
    • Experience with troubleshooting of NGS assay protocols including library preparation, target enrichment, and sequencing is a plus
    • Experience with the development and implementation of clinical laboratory tests under CAP/CLIA or FDA/regulated environments including document, design or change controls
    • Experience with statistical programming or software (e.g, R, JMP) a plus
    • Attention to detail, safety, good laboratory practice, and good documentation practice
    • Strong verbal and written communication skills and willingness to collaborate cross-functionally in a fast-paced and dynamic environment

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 .

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Posting ID: 635863623Posted: 2021-08-22Job Title: Process Development Engineer