Senior Scientist Technical Operations #4375

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.

What We Do

GRAIL is a healthcare company whose mission is to detect cancer early when it can be cured. GRAIL is using the power of high-intensity sequencing population-scale clinical studies and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology and to develop and commercialize pioneering products.

Why Work With Us

Everything we do is guided by our mission to detect cancer early when it can be cured. It’s the reason we’re here and it’s no small task. The right people make all the difference. That’s why we’re looking for those who strive to share their knowledge contribute their skills inspire each other and commit to something bigger than themselves.

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