Senior Staff Scientist - CDx Development

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
Jun 09, 2021
Ref
2142654731
Hotbed
Biotech Bay
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.

We are looking for a highly motivated and experienced Senior Staff Scientist to join our development and validation team! The ideal candidate should have a proven track record developing products or lab tests from feasibility to launch. Experience working in a regulated environment under design control is important. Strong technical skills are essential. This individual will be a collaborative teammate with the ability to work effectively and collegially with a diverse group of people.

You Will:

• Provide strategic and technical guidance on product development teams for regulated products to assure compliance with regulations and the highest level of quality
• Use your knowledge of regulatory and quality systems and design control guidance to lead the team in planning product development phases including verification and validation studies with full knowledge of requirements from FDA, CAP/CLIA and IVDR.
• Apply knowledge of biochemistry and molecular biology to develop robust products with streamlined workflows
• Collaborate closely with data analysis team to plan experiments and interpret results
• Work 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

Your Background Will Include:

• Ph.D in Molecular Biology or Biochemistry
• Experience developing IVD products and interacting with FDA
• 9+ years of industry experience in the Life Sciences or Diagnostics industry
• Minimum 6 years of development experience with a proven track record developing successful products
• An excellent understanding of genetic assays and molecular biology
• Experience with NGS and/or circulating nucleic acid based tests
• Desire to partner with QA and RA to develop increase compliance and quality
• Experience with design, execution and interpretation of DOEs
• Experience designing and executing stability and analytical validation studies
• Experience working under design control
• Must be a detail-oriented, critical thinker, team player
• Strong verbal and written communication skills
• Ability to work effectively with and learn from others
• An ability to be flexible 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 .