Method Development and Validation Research Technician I
Core
Develop, validate, and transfer immunoassays and bioanalytical methods (ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, Elispot) for client studies.
Role type
Research Technician I (Bioanalytical Method Development)
Builds
Fit-for-purpose assays and validated methods for pharmaceutical and clinical studies
Domain
Life Sciences / Bioanalytical Chemistry
Required skills
Immunoassay design and validation, GxP/GLP compliance, Technical documentation, Data compilation, IT systems (ERP, LIMs), Statistical analysis, Troubleshooting
Preferred skills
MS Office proficiency, Multitasking, Time management, Cross-functional support
Technologies
ERP, LIMs, ELISA, Flow Cytometry, Elispot
Responsibilities
Perform development, validation, and transfer of immunoassays; Design and manage routine and non-routine projects; Create validation plans and deviation reports; Compile data and collaborate on project progression; Apply IT systems for data management; Communicate project updates to internal teams and external clients; Assist in assay re-qualification; Adhere to Regulatory Compliance (GxP, FDA, GLP, GDP, GCP, OECD, CLIA) and internal SOPs; Conduct activities safely per EHS requirements.
Seniority
Junior to Mid-level, hands-on IC