Biomarker Immunoassay Scientist - GxP Lab Ops

Thermo Fisher Scientific Inc.; Letchworth; On-site; GBP 32,000 - 42,000; Full time

Job summary

Thermo Fisher Scientific Inc. in Stevenage is seeking a scientist to validate and implement immunoassay methods for soluble biomarker analysis in early-stage clinical studies.

You will perform sample analysis and deliver biomarker results to study teams in a timely manner, following data integrity guidelines and GCP-informed procedures. Within the Analytical Services team, you will generate and review analytical methods, reports, SOPs and other documentation, while supporting day-to-day lab

Qualifications

• Experience running bioanalytical or biomarker studies in a GxP environment with focus on data integrity and record keeping.
• Experience performing quantitative immunoassays using MSD, ELISA or SIMOA.
• Understanding regulatory aspects of human sample management and GCP.

Responsibilities

• Validate and implement immunoassay methods for soluble biomarker analysis in early-stage clinical studies.
• Perform sample analysis and deliver biomarker results to study teams with data integrity.
• Generate and review analytical methods, reports, SOPs and related documentation.
• Facilitate day-to-day lab operations including equipment, consumables and reagent management.
• Maintain a safe work environment consistent with local client policies and contribute to process improvements.

Skills

Bioanalytical experience

GxP/regulatory experience

Data integrity

Education

Biology/biochemistry/chemistry/pharmacology degree

Tools

LIMS (Watson)

Immunoassay techniques (MSD/ELISA/SIMOa)

Job description

Thermo Fisher Scientific Inc. in Stevenage is seeking a scientist to validate and implement immunoassay methods for soluble biomarker analysis in early-stage clinical studies.

You will perform sample analysis and deliver biomarker results to study teams in a timely manner, following data integrity guidelines and GCP-informed procedures. Within the Analytical Services team, you will generate and review analytical methods, reports, SOPs and other documentation, while supporting day-to-day lab