Senior Scientist Process Integration # 4375 at GRAIL

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Biotechnology, DiagnosticsIndustries

Requirements

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

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

Skills

Key technologies and capabilities for this role

Next-Generation SequencingNGSProcess IntegrationProcess OptimizationAssay DevelopmentValidation ProtocolsCLIACAPNYSISO 13485FDAHigh-Throughput LabMSATTroubleshootingClinical Laboratory

Questions & Answers

Common questions about this position

What is the salary range for the Senior Scientist Process Integration role?

This information is not specified in the job description.

Is this Senior Scientist role remote or onsite?

This information is not specified in the job description.

What qualifications are preferred for this position?

Preferred qualifications include a PhD in Life Sciences, Molecular Biology, Biochemistry, Bioengineering, or a related field, along with proven experience in technology transfer of assays and launching new products.

What is the company culture like at GRAIL?

GRAIL has built a multi-disciplinary organization of scientists, engineers, and physicians, working collaboratively with cross-functional teams such as MSAT, Engineering Operations, and Clinical Lab to advance early cancer detection.

What makes a strong candidate for this Senior Scientist role?

A strong candidate has deep expertise in the full laboratory workflow from pre-analytical to post-analytical phases, process optimization, and comprehensive knowledge of clinical laboratory regulatory frameworks like CLIA, CAP, NYS, ISO 13485, and FDA.

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters

2016Year Founded

$1,765.5MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.

Significant net losses may affect investor confidence and long-term sustainability.

High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.

The Galleri test screens for over 50 cancers with a single blood draw.

GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.

Revenue from Galleri grew 52% year-over-year, indicating strong market demand.

GRAIL's technology aligns with trends in personalized and preventative medicine.

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