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Scientist – Reagent Health And Performance / Surveillance

Roche
2+ years
preferred by company
Seattle, United States
1 May 14, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines

Scientist – Reagent Health and Performance / Surveillance

Company: Roche
Department: Research & Development – Oncology Assay Development
Location: Seattle, Washington, United States
Work Mode: On-Site
Job Type: Full-Time
Category: Research & Development
Job ID: 202605-111929


Position Overview

Roche is seeking a Scientist – Reagent Health and Performance / Surveillance to join its Oncology Assay Development organization.

This role focuses on reagent product monitoring, risk-based testing, product surveillance, and lifecycle performance management to ensure the quality, reliability, and stability of diagnostic reagents.

The scientist will support both new product commercialization and post-launch surveillance of commercially available products, helping assess product risk, investigate failures, optimize performance, and maintain regulatory compliance.

This is an individual contributor role requiring strong scientific expertise, analytical rigor, and cross-functional collaboration.


Department Overview

The Reagent Health and Performance / Surveillance team is responsible for monitoring diagnostic reagent performance throughout the product lifecycle.

Core focus areas include:

  • Product performance surveillance
  • Risk-based testing strategies
  • Real-time stability testing
  • Expiration dating support
  • Failure investigations
  • Product lifecycle quality monitoring
  • Cross-functional scientific support

The team works closely with:

  • Product Lifecycle Management
  • Research & Development
  • Manufacturing
  • Quality Assurance
  • Regulatory Affairs
  • Global operational teams

Key Responsibilities

Product Monitoring & Surveillance

  • Monitor reagent product performance across the product lifecycle.
  • Conduct surveillance activities for on-market diagnostic products.
  • Evaluate reagent health, performance trends, and operational risks.
  • Support expiration dating programs through real-time stability testing.

Risk Assessment & Product Investigation

  • Perform risk evaluation for commercial reagent portfolios.
  • Design fit-for-purpose testing strategies to assess product risks.
  • Investigate product failures, deviations, and performance concerns.
  • Support root cause analysis and corrective action planning.

Research & Innovation

  • Execute research and development activities to improve products and processes.
  • Identify technical challenges and propose innovative scientific solutions.
  • Contribute to development of potentially patentable technical improvements.

Experimental Design & Project Execution

  • Plan and conduct scientific experiments aligned with project goals.
  • Apply advanced scientific methodologies, including:
    • DOE (Design of Experiments)
    • Product performance testing
    • Stability analysis
    • Risk-based validation strategies
  • Ensure high-quality experimental execution.

Data Analysis & Continuous Improvement

  • Analyze experimental and product performance data.
  • Draw evidence-based scientific conclusions.
  • Drive continuous process improvements.
  • Support "Quality First Time" standards and operational excellence initiatives.

Cross-Functional Collaboration

  • Collaborate with:
    • Product Lifecycle teams
    • Development teams
    • Manufacturing
    • Quality Assurance
    • Regulatory Affairs
    • Global operational teams
  • Provide technical expertise during cross-functional decision-making.

Communication & Technical Leadership

  • Present scientific findings, technical recommendations, and performance insights to stakeholders.
  • Participate in technical reviews, project meetings, and collaborative planning sessions.
  • Share expertise with colleagues and project teams.

Strategic Support

  • Support project planning, scientific prioritization, and experimental strategy development.
  • Recommend workflow optimizations and process improvements under senior leadership guidance.

Required Qualifications

Education

Preferred background in:

  • Biochemistry
  • Molecular Biology
  • Chemistry
  • Biotechnology
  • Life Sciences
  • Biomedical Sciences
  • Related scientific discipline