FSP Senior Scientist, Biomarkers
Core
Testing of clinical biological samples for various biomarkers using immunoassay platforms in a GCP compliant environment.
Role type
Senior Scientist, Biomarkers
Builds
Clinical biomarker data for pharmaceutical/biopharmaceutical clinical trials
Domain
Life Sciences / Clinical Research / Bioanalytical Laboratory
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Immunoassay method development and validation, GCP compliance, regulated document preparation, clinical sample handling, data accuracy review, laboratory equipment maintenance
Preferred skills
Watson LIMS experience, experience with MSD and Quanterix platforms
Technologies
MSD, Quanterix, Watson LIMS
Responsibilities
Develop and validate immunoassay methods to support clinical biomarker endpoints; Prepare regulated documents including validation plans, reports, and SOPs; Perform routine testing of clinical biological samples (primarily serum); Execute assays on immunoassay platforms following SOPs; Document all laboratory activities in compliance with GCP and regulatory requirements; Review assay results for accuracy and completeness; Maintain laboratory equipment, reagents, and consumables
Seniority
Senior, hands-on IC
