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 the bay area of 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, Technical Operations is responsible for supporting sustaining operations and introducing new assays and diagnostic products into GRAIL’s high‑throughput, regulated laboratory environment. This individual contributor partners closely with MSAT, Assay Development, Engineering Operations, and the Clinical Lab to lead process integration, improvement, monitoring, and troubleshooting. The ideal candidate brings deep expertise across the end‑to‑end laboratory workflow—from pre‑analytical through post‑analytical—strong process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks.
This position is onsite full-time, with 5 days per week at our facility. Additionally, the role requires participation in a rotating schedule for weekend and holiday coverage (when applicable), as part of ensuring continuous support for critical laboratory operations.
Responsibilities:
- Lead or assist in process troubleshooting activities, including root-cause analysis and impact assessments, resolving technical challenges.
- Monitor process performance, analyze data and metrics, and contribute to process monitoring and improvement strategies to sustain high-quality, efficient operations.
- 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.
- Identify process gaps and contribute to or lead process improvement initiatives to enhance efficiency, reliability, and quality.
- 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.
- Lead complex investigations and root-cause analyses; implement effective CAPAs and preventive measures with clear verification of effectiveness.
- Support lab readiness: training, tech transfer materials, troubleshooting guides, and operational playbooks for Clinical Lab teams.
- Analyze complex datasets and present insights to technical and non-technical stakeholders to guide decisions.
- Contribute to inspection/audit readiness and support interactions with CAP/CLIA, state agencies (e.g., NYS), and other regulatory bodies as needed.
- These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.
Required 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 $122K - $147K. Actual base pay will consider skills, experience and location.
This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.
GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position.
GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!
Top Skills
Jmp
Laboratory Information Management Systems
Mes
Minitab
Next-Generation Sequencing
Python
R
Tableau
GRAIL Menlo Park, California, USA Office
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. We also have a number of employees who are working remotely. Our bay area office has a employees working in our labs, software engineering, clinical development and more.
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