GRAIL · 1 month ago
Senior Scientist Technical Operations # 4375
Durham, NC
Full-time
Onsite
Mid, Senior Level
$119K/yr - $142K/yrGRAIL is a healthcare company focused on pioneering new technologies for early cancer detection. The Senior Scientist, Technical Operations will support sustaining operations and introduce new assays and diagnostic products in a high-throughput, regulated laboratory environment, collaborating with various teams to enhance efficiency and ensure compliance with regulatory standards.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
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
Qualification
Required
Deep expertise across the end-to-end laboratory workflow—from pre-analytical through post-analytical
Strong process optimization experience
Thorough understanding of clinical laboratory regulatory frameworks
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
Preferred
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
Benefits
Flexible time-off
A 401k with a company match
Medical, dental, vision plans
Carefully selected mindfulness offerings
Company
GRAIL
Grail is a healthcare company that develops pan-cancer screening tests designed to detect cancers at an early stage.
Founded in 2016
1001-5000 employees
H1B Sponsorship
GRAIL has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (26)
2023 (23)
2022 (46)
2021 (25)
2020 (9)
Funding
Current Stage
Public CompanyTotal Funding
$2.44BKey Investors
ARCH Venture PartnersIllumina
2025-10-20Post Ipo Equity· $325M
2025-10-16Post Ipo Equity· $110M
2024-06-13IPO
Leadership Team
Satnam Alag
Senior Vice President Software Engineering and Chief Security Officer
Joshua J. Ofman
President
Recent News
2026-01-09
2026-01-06
Company data provided by crunchbase