FSP Senior Scientist-Scientific Writer

Develop and validate immunoassay methods to support clinical biomarker endpoints using platforms such as Meso Scale Discovery and Quanterix. Perform routine testing of clinical biological samples, primarily serum, in a Good Clinical Practice compliant environment while preparing regulated documents including validation plans, analytical reports, and SOPs. Execute assays following established standard operating procedures, review results for accuracy, and document all laboratory activities clearly and contemporaneously. Maintain laboratory equipment and reagents to ensure operational readiness and support clinical study workflows from sample receipt to data reporting. This fully onsite role is based at a customer's site in Collegeville, PA, with a standard Monday-to-Friday schedule.