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Staff / Lead Process Engineer (Tech Ops) - RTP #2165

Employer
GRAIL, LLC
Location
Raleigh, North Carolina
Start date
Jul 25, 2022
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Job Details

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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

GRAIL is seeking a Process Engineer in Technical Operations in our North Carolina (RTP) facility.
The ideal candidate is a team player with hands-on experience developing, implementing, qualifying,
executing, and troubleshooting automated molecular testing procedures and a willingness to lead
and teach others. The candidate will be encouraged to think outside of the box and creatively solve
problems related to the optimization, verification, and execution of NGS-based workflows. They will
work collaboratively across many organizational functions, using a data-driven approach to identify
areas for improvement. The successful candidate will demonstrate an ability to independently design
and execute experiments, develop compliant (GMP/GCLP/ISO/CAP/CLIA) qualification plans, and
serve as SME to support validation activities. The candidate will be instrumental in documenting and
resolving non-conformances, and performing in-depth investigations to support the implementation of
process improvements in support of GRAIL operations.
YOU WILL:
  • Use deep knowledge of automated liquid handling systems, NGS workflows, general
  • biochemistry and molecular biology, and scientific best practices to develop novel solutions
  • to assess verification/validation readiness, identify and address gaps, improve assay
  • robustness
  • Independently design, execute, and analyze data from experiments to support the
  • optimization, characterization, and validation of novel automated NGS-based assays
  • Supervise cross-functional testing and documentation from initiation to completion of assay
  • version updates
  • Work closely with Technical Operations Verification and Validation team members to identify
  • and document methods, parameters, acceptance criteria appropriate for V&V testing
  • Employ data-driven approach to identify, design, characterize, and effectiveness-check
  • improvements
  • Identify internal SMEs and lead cross-functional teams to identify appropriate parameters
  • and metrics for process monitoring
  • Summarize proposed method changes/improvement accurately and succinctly, and
  • document appropriately within a GMP/ISO regulatory-compliant Quality Management System
  • Support design and maintenance of databases to inform data-driven process improvements
  • Serve as Technical Operations SME for equipment, equipment performance specifications,
  • and processes related to execution of current GRAIL automated NGS assays
  • Use Lean/6-Sigma methods to research and characterize areas of improvement
  • Use productivity software to track and report progress
  • Support nonconformance containment activities, as needed
  • Mentor junior scientific and engineering Technical Operations staff

YOUR BACKGROUND AND QUALIFICATIONS WILL INCLUDE:
  • Minimum of B.Sc./M.S. in BioEngineering, Molecular Biology, Biochemistry, or a related field
  • with 8+ years of related experience. Job Title/Level will be based on education and
  • demonstrated experience
  • Demonstrated record of designing, implementing, and troubleshooting automated liquid
  • handling workflows
  • Familiarity with NGS workflows and supporting QC methods (FA, CE, qPCR)
  • Demonstrated technical leadership of cross-functional teams
  • Willingness and ability to learn new techniques independently and quickly
  • Excellent written, organizational, and verbal communication skills (fluency in English)
  • Strong interpersonal, negotiation, and influencing skills
  • General digital literacy and proficiency in G-Suite and/or Microsoft Office Suite required
  • General proficiency in basic multivariate statistical analyses, use of statistical software (JMP,
  • Tableau, SPS, Minitab) required
  • Lean Six Sigma certified: minimum yellow belt required, green/black strongly preferred
  • Proficiency with R, Python, and/or SQL strongly preferred
  • Automated NGS library preparation strongly preferred
  • General knowledge of software development processes preferred

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine and “Up to Date” with any recommended booster. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered; "Up to Date" means having timely received any COVID-19 vaccine booster(s) in accordance with CDC guidelines. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.

Company

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.

LEADERSHIP:

CEO: Bob Ragusa

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Find Us
Website
Phone
833-694-2553
Location
1525 O'Brien Drive
Menlo Park
California
94025
United States
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