The Senior Scientist will lead process integration and optimization for new assays in a regulated lab, working closely with cross-functional teams to ensure compliance and improve processes.
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.
The Senior Scientist, Process Integration, is responsible for the scientific and technical advancement associated with introducing new assays and diagnostic products into Grail’s high-throughput, regulated laboratory environment. This individual contributor role focuses on supporting key activities in process integration, improvement, monitoring, and troubleshooting, in close partnership with cross-functional teams such as MSAT, Engineering Operations, and Clinical Lab. The ideal candidate brings deep expertise in the full laboratory workflow—from pre-analytical to post-analytical phases—process optimization, and comprehensive knowledge of clinical laboratory regulatory frameworks.
Responsibilities:
- Support the transfer and implementation of new assays and diagnostic products from development into production, ensuring robust performance across all workflow phases.
- Develop, optimize, and document validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA, and other applicable standards.
- Provide scientific and technical support to MSAT, Engineering Operations, and Clinical Lab teams.
- Evaluate, qualify, and implement alternative reagents and vendors to maintain continuity and strengthen lab operations.
- Monitor process performance, analyze data and metrics, and contribute to process monitoring and improvement strategies to sustain high-quality, efficient operations.
- Identify process gaps and contribute to or lead process improvement initiatives to enhance efficiency, reliability, and quality.
- Lead or assist in process troubleshooting activities, including root-cause analysis and impact assessments, resolving technical challenges.
- Prepare comprehensive technical documentation, scientific reports, and regulatory submission materials as required.
- Maintain high standards of scientific rigor, quality, and regulatory compliance in all process integration activities.
Preferred Qualifications:
- PhD in Life Sciences, Molecular Biology, Biochemistry, Bioengineering, or a related field.
- Proven experience in technology transfer of assays and launching new products in a regulated diagnostic laboratory.
- Direct, hands-on experience with end-to-end clinical workflows (pre-analytical, analytical, and post-analytical).
- Strong knowledge of high-throughput laboratory automation and advanced instrumentation.
- Deep understanding of clinical laboratory regulatory standards, including CLIA, CAP, NYS, ISO 13485, and FDA.
- Experience with or understanding of reagent manufacturing and alternative vendor qualification processes.
- Experience participating in audits (internal, regulatory, or client-driven).
- Excellent skills in technical documentation and scientific writing.
- Demonstrated ability to collaborate effectively across MSAT, Engineering Operations, and Clinical Lab teams.
- Six Sigma certification or significant experience with Lean, Kaizen, or other process improvement methodologies.
- Hands-on experience with data analytics tools and platforms (e.g., JMP, Minitab, R, Python, Tableau) for process monitoring, analysis, and reporting.
- Experience with laboratory information management systems (LIMS) or MES.
- Advanced data analysis skills applied to laboratory operations and quality improvement.
- Experience supporting laboratory scale-up, automation, or operational excellence projects.
Expected full time annual base pay scale for this position is $119K - $142K. Actual base pay will consider skills, experience and location.
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.
Top Skills
Jmp
Laboratory Information Management Systems
Mes
Minitab
Next-Generation Sequencing
Python
R
Tableau
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