Senior Scientist/Scientist 2 (IVD)

Employer
GRAIL, Inc.
Location
Raleigh, North Carolina
Posted
Oct 08, 2021
Hotbed
Bio NC
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

GRAIL is a life sciences company whose mission is to detect cancer early when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical trials, and state of the art Computer Science and Data Science to improve the scientific understanding of cancer biology and develop blood tests for early-stage cancer detection! We are seeking hardworking and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.We are looking for a highly motivated and experienced Senior IVD Scientist to join our Development team. The ideal candidate should have a proven track record developing products or lab tests from feasibility to launch, contributing to the development, optimization and validation of assays for cancer detection. Experience working in a regulated environment under design control is important. Strong technical and troubleshooting skills are essential. Must be a strong great teammate with the ability to work effectively and collegially with a diverse group of people!
You will:
  • Apply knowledge of biochemistry and molecular biology to develop robust products with streamlined workflows
  • Use your knowledge of regulatory and quality requirements and design control guidance to lead the team in planning and executing experiments, including but not limited to assay optimization, guard banding, verification and validation studies.
  • Work closely with data analysis team to design experiments and interpret resultsWork closely with clinical operations team to understand requirements and transfer tests
  • Document your work per Quality requirements
  • Supervise and train scientists and research associates
  • Collaborate with departmental and cross-functional team members
  • Support Regulatory Affairs Team by assisting with responses to regulatory agency questions (CLIA, CAP, FDA) regarding product design and validations

Preferred Background:
  • Ph. D in Molecular Biology or Biochemistry
  • 5+ years of industry experience in the Life Sciences or Diagnostics industry
  • Minimum 3 years of development experience with a proven track record developing successful products
  • More than 2 years experience with NGS and/or circulating nucleic acid based tests a plus
  • Experience designing and guiding the execution of analytical / validation studies for PMA submissions
  • Experience acting as a subject matter expert during regulatory audits
  • Experience working in a regulated environment, CLIA, CAP, FDA, etc
  • An excellent understanding of genetic assays and molecular biology
  • Strong analytical and troubleshooting skills
  • Experience transferring a product to a clinical laboratory
  • Experience with design, execution and interpretation of DOEs
  • Experience working under design control
  • Strong verbal and written communication skills and willingness to collaborate cross-functionally in a fast paced and dynamic environment
  • Strong technical writing skills
  • Tolerance for change and willingness to find solutions
  • Occasional travel

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. 

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, 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.