CDx Clinical Lab Scientist I — High-Complexity Testing

F. Hoffmann-La Roche AG; Northern (KY); Hybrid; USD 50,000 - 79,000; Full time

Job summary

Roche in the United States seeks a CDx Clinical Lab Scientist I to perform high-complexity testing on clinical specimens, interpret results, and ensure study protocol compliance under CAP/CLIA and ISO guidelines.

You will monitor IHC, ISH, molecular assays, and immunoassays, document outcomes with GDP, and support clinical trials while maintaining data integrity and safety standards in a collaborative lab environment.

Qualifications

• Bachelor's degree in life sciences.
• Hands-on lab experience with IHC/ISH and molecular biology.
• Experience with CAP/CLIA and GDP/regulatory compliance.
• Strong attention to detail and organizational skills.
• Good written and verbal communication; basic software skills.
• HT/HTL (ASCP) and QIHC preferred.

Responsibilities

• Perform high-complexity testing on clinical specimens.
• Monitor IHC, ISH, molecular assays, and immunoassays.
• Ensure CAP/CLIA compliance and safety protocols.
• Document sample processing and results with GDP.
• Investigate laboratory failures and assist with root-cause analysis.
• Maintain instrument readiness and routine maintenance.

Skills

Attention to detail

Organizational skills

Verbal communication

Written communication

Laboratory information systems

Statistical analysis

IHC/ISH familiarity

Education

Bachelor's Degree in life sciences

Tools

IHC techniques

ISH techniques

Histology workflows (CAP/CLIA)

Immunoassays

Molecular biology techniques

Job description

Roche in the United States seeks a CDx Clinical Lab Scientist I to perform high-complexity testing on clinical specimens, interpret results, and ensure study protocol compliance under CAP/CLIA and ISO guidelines.

You will monitor IHC, ISH, molecular assays, and immunoassays, document outcomes with GDP, and support clinical trials while maintaining data integrity and safety standards in a collaborative lab environment.