ELISA Method Development and Validation Research Technician I
Core
Develop, validate, and transfer immunoassays and bioanalytical methods (ELISA, ADA, PK, Nab, MSD, cell-based, Flow Cytometry, Elispot) for client bioanalytical projects.
Role type
Research Technician I (Bioanalytical Method Development and Validation)
Builds
Fit-for-purpose assays and validated bioanalytical methods for clinical studies
Domain
Pharmaceutical/Clinical Laboratory / Bioanalytical Chemistry
Required skills
ELISA method development and validation, immunoassay design and execution, regulatory compliance (GxP, FDA, GLP, GDP, GCP, OECD, CLIA), technical documentation, data compilation and reporting, statistical analysis, assay troubleshooting, laboratory safety (EHS)
Preferred skills
MS Office proficiency, cross-functional collaboration, time management, multitasking
Technologies
ERP, LIMs, instrumentation software
Responsibilities
Perform development, validation, and transfer of immunoassays; design, plan, and manage routine and non-routine projects; create validation plans, test methods, and deviation reports; compile data and collaborate on project progression; communicate project updates to internal teams and external clients; assist in assay re-qualification; adhere to SOPs and regulatory procedures; maintain attendance and punctuality.
Seniority
Junior to Mid-level, hands-on IC