Associate Scientist - Immunoassay Development
Bethesda Metro Area, MD
BS or MS in Biochemistry, Biology, or Related with 5 - 8 years of relative experience
Experience with SoftMax Pro Software
Strong knowledge of MSD (Meso Scale Discovery)
Strong knowledge of ELISA (enzyme-linked immunosorbent assay)
Lab based position with minimal supervision to develop, qualify and/or validate immunoassays in support of clinical and non-clinical GCP/GLP sample analysis for PK, ADA, neutralizing antibody, and biomarkers.
Major Duties and Responsibilities:
Executes and provides significant input into the development, planning, and design of experiments, and interpretation of results.
Records development experiments (and other experiments as required) fully and clearly in the electronic Laboratory Notebook (eLN) system.
Orders, ensures quality, tracks, and manages critical assay reagents.
Troubleshoots assays and finds solutions to project and assay issues through literature searches, internal resources, other departments
Validates immunoassay methods in accordance with applicable regulatory guidelines.
Is compliant with and applies knowledge of GxP on a daily basis to ensure regulatory inspection readiness.
Prepares validation protocols, qualification reports, validation reports and/or summaries of assay optimization and updates to management.
Communicates, investigates, and reports on issues/problems that may impact timelines and the accuracy or reliability of laboratory data.
Writes, updates, and reviews SOPs.