Senior Scientist Technical Operations # 4375

Grail•Durham, NC

33d•$119,000 - $142,000

About The Position

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, Technical Operations is responsible for supporting sustaining operations and introducing new assays and diagnostic products into GRAIL's highâthroughput, 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 endâtoâend laboratory workflow-from preâanalytical through postâanalytical-strong process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks.

Nice To Haves

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.

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