Staff Scientist - IVD Product Development

Employer
GRAIL, Inc.
Location
Raleigh-Durham, NC, United States
Posted
Feb 14, 2021
Ref
747481855
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
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.

As a Staff Scientist at GRAIL, you will join an exceptional and innovative product development team responsible for delivering commercial scale NGS assays. You will lead critical studies that support new product introduction and regulatory submissions by providing technical expertise in the planning, execution and analysis of laboratory experiments. The ideal candidate should have extensive experience developing or validating assays in a regulated environment, possess critical thinking skills, and be a self-motivated team player.

You Will:

• Act as a core technical lead on product development projects leading to new product introductions and regulatory submissions.
• Drive development efforts to optimize assay performance and improve laboratory processes.
• Work effectively on cross-functional teams to plan, design and execute verification/validation studies.
• Perform complex analysis of large genomic data sets in collaboration with Bioinformatics and Biostatistics.
• Be responsible for documentation in compliance with Good Laboratory Practices and Quality Systems Requirements.
• Present project updates, data analysis, and experimental conclusions at technical meetings.
• Mentor junior team members.

Your Background Will Include:

• Ph.D in Molecular Biology, Biochemistry, or related field with 6-8 years+ industry experience.
• IVD product development experience highly desired, knowledge of regulatory requirements, experience working under Design Control, authoring study protocols and reports.
• Hands-on experience with Next Generation Sequencing workflows or assays is a plus.
• In-depth knowledge of molecular biology techniques and workflows is required.
• Experience with statistical programming and software (e.g., R, JMP) is a plus.
• Experience with LIMS, automation, and Document Control is desired.
• 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 .