ELISA Method Development and Validation Research Scientist I
Core
Develop, validate, and transfer immunoassays and bioanalytical methods (ELISA, ADA, PK, Nab, MSD, cell-based, Flow Cytometry, Elispot) for client studies.
Role type
Junior-to-mid level IC bioanalytical research scientist
Builds
Fit-for-purpose assays and validated bioanalytical methods
Domain
Pharmaceutical/CRO clinical laboratory services
Required skills
ELISA method development and validation, immunoassay design, regulatory compliance (GxP, FDA, GLP, GDP, GCP, OECD, CLIA), technical documentation, data compilation, statistical analysis, assay troubleshooting, project management
Preferred skills
Experience in drug discovery and development, cross-functional collaboration, time management, laboratory safety protocols
Technologies
ERP systems, LIMs, MS Office, instrumentation software
Responsibilities
Design, plan, perform, and manage routine and non-routine bioanalytical projects; Create validation plans, test methods, worksheets, and deviation reports; Compile data and collaborate with Scientific Directors; Communicate project updates to internal teams and external clients; Assist in assay re-qualification; Adhere to SOPs and EHS requirements
Seniority
Junior to Mid-level, hands-on IC
