Job details

Senior Staff Scientist, Technical Operations #4070

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in Menlo Park, California, 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 grail.com.

This individual will be responsible for establishing, implementing, maintaining, and improving GRAIL’s product labeling program and acts as technical lead supporting technical operation on process monitoring, troubleshooting and investigation. This person works closely with Regulatory, Quality, Supply Chain, R&D and Clinical Laboratory. The person in this role consistently applies critical thinking skills and good judgment to solve broad, complex problems, effectively establishing and cascading functional strategy and decisions across teams and communicating status and recommendations to executive management.

Key responsibilities include providing expertise and strategic oversight to 1) ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485, ISO 14971, ISO 15189, 21 CFR 820, 21 CFR 809, and related medical device regulations and 2) ensure technical operation is effectively, and timely identifying and containing Clinical Lab production issues by supporting process monitoring, troubleshooting and investigation.

Responsibilities:

Ownership of efficient, effective, and compliant processes and their governing procedures for GRAIL’s product labeling.
Assigns label part numbers to all device labeling.
Establishes and maintains labeling specifications (printed and electronic).
Establishes and maintains source artwork files adhering to labeling specifications.
Ensures all label claims are substantiated through the Design History File in partnership with Regulatory and Design teams.
Initiates and drives to completion Veeva change control workflows for labeling specifications, source artwork, and final labels initiation and change management.
Represents the Labeling Program as Subject Matter Expert during audits and inspections
Maintains and continually improves the Labeling Program to ensure state of the art labeling controls at GRAIL.
Where applicable, acts as technical lead on process monitoring, troubleshooting and deeper investigations

Preferred Qualifications:

Bachelor’s degree in a science, engineering, or other technical area.
12+ years of experience with medical device or pharmaceutical product labeling operations or NGS assays.
Working knowledge of applicable medical device regulations and standards including but not limited to 21 CFR 809, 21 CFR 820, ISO 13485, ISO 14971, ISO 15189, MDR/IVDR.
Proven leadership, organizational and management skills to drive effective, compliant cross-functional decision making.
Excellent written and verbal communication skills and attention to detail.
Ability to comprehend and interpret technical information related to GRAIL's product claims.

Desired Qualifications and experience

Master’s degree in a related technical area, or MBA.
Experience preparing for, leading, and supporting regulatory inspections/audits and effectively responding to findings.

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment 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. GRAIL maintains a drug-free workplace.

GRAIL Glassdoor Company Review

3.9

GRAIL DE&I Review

4.1

CEO of GRAIL

Bob Ragusa

Approve of CEO

Average salary estimate

$140000 / YEARLY (est.)

min

max

$120000K

$160000K

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What You Should Know About Senior Staff Scientist, Technical Operations #4070, GRAIL

At GRAIL, we are on a mission to revolutionize cancer care by detecting it early, when it’s most treatable. As a **Senior Staff Scientist, Technical Operations**, you will play a pivotal role in our innovative journey based in Menlo Park, CA. Here, you’ll work alongside a dynamic team of scientists, engineers, and healthcare professionals, applying your expertise in next-generation sequencing (NGS) and medical device regulations to enhance our product labeling program. Responsibilities will include ensuring compliance with regulations such as the EU In Vitro Diagnostic Regulation (IVDR) and various ISO standards. You'll oversee the establishment and maintenance of efficient labeling processes and specifications, ensuring all our label claims stand up to scrutiny through collaboration with Regulatory and Design teams. Your critical thinking and strategic decision-making will directly influence our product operations, helping to swiftly identify and address production issues in our clinical lab. As the subject matter expert during audits and inspections, your leadership will guide teams through compliance challenges, making you an integral part of GRAIL's mission to shape the future of cancer detection. Join us in this exciting opportunity to make a real difference in healthcare and be part of a team dedicated to saving lives.

Frequently Asked Questions (FAQs) for Senior Staff Scientist, Technical Operations #4070 Role at GRAIL

What are the responsibilities of a Senior Staff Scientist, Technical Operations at GRAIL?

As a **Senior Staff Scientist, Technical Operations** at GRAIL, your responsibilities span establishing and maintaining compliance for product labeling operations, overseeing labeling specifications, and managing the team that ensures efficient troubleshooting and investigations within clinical lab production. You will also be a key player in aligning teams across Regulatory, Quality, and R&D, ensuring that our labeling operations effectively meet regulatory standards while driving continuous improvements.