Staff Scientist Product Support and Improvement (Assay Development)

Employer
GRAIL, LLC
Location
Menlo Park, CA
Posted
May 18, 2022
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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

GRAIL is seeking a Senior Scientist in the Assay Development team at our Menlo Park R&D headquarters to lead the development of process improvements and the investigation of issues arising in Operations through root cause analysis and troubleshooting studies.  You will establish a bridge between Product Development and Operations by coordinating a variety of development, technology transfer, and product support activities. You will be hands-on in the lab and be required to design, execute, and verify new process improvements with the necessary contribution to documents required for change control, corrective action preventive action (CAPA), and non-conformance reports. The ideal candidate is a technically-rigorous team player with proactive and forward critical thinking experienced in Sustain & Support activities for automated next-generation sequencing (NGS) workflows. 




You will...
  • Support the triage of issues observed in the Lab Operations by providing timely, technical, and scientific support to assess, and resolve any incidents and/or non-conformance issues that may arise during sample processing.
  • Participate in risk assessment activities to determine impact assessment and prioritization of troubleshooting and process improvement activities.
  • Participate in containment, corrective, and preventive actions by working collaboratively with Quality Assurance, Lab Operations, and Manufacturing Science & TechnologyLead the development of process improvements by engaging with the different functions within the Product Development team to gather feedback and present results.
  • Plan, execute and analyze experiments for creating Design of Experiments (DOE), study protocol, and study report by collaborating with scientists, engineers, data scientists, and biostatisticians. Facilitate the implementation of the process improvements by drafting SOP, drafting verification and validation study protocol, and study report by working under change control.

  • 3+ years of industry work experience in Process Development, Sustain & Support activitiesM.S. degree or Ph. D in Molecular Biology, Biochemistry, or relevant disciplines with a minimum of 5+ years of work experience in an industry setting 
  • Strong verbal and written communication skills and willingness to collaborate cross-functionally in a fast-paced and dynamic environment
  • Experience with troubleshooting NGS assay protocols including library preparation, target enrichment, sequencing with an automated liquid handler 
  • Experience with the development and implementation of clinical laboratory tests under CAP/CLIA or IVD/FDA/regulated environmentsWorking knowledge of using tools such as PFMEA, Process Flow, Control Charts, Six Sigma, DMAIC, 5-Whys, Fault Tree Analysis and Fishbone Diagrams is a plusExperience with statistical programming or software (e.g, R, JMP) is a plus
  • Attention to detail, safety, good laboratory practice, and good documentation practice

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, 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.