Method Development and Validation Research Technician II
Core
Supports client bioanalytical projects by developing, validating, and transferring immunoassays and bioanalytical methods (RIA, EIA, Flow Cytometry, Cell-Based Assays) with limited supervision.
Role type
Senior IC research technician (bioanalytical method development and validation)
Builds
Contracted method development and validation services for client studies
Domain
Pharmaceutical/CRO clinical laboratory
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ligand binding assay design, immunoassay development, method validation, reagent qualification, antibody characterization, GxP compliance (FDA/GLP/GCP/OECD/CLIA), statistical analysis, root cause analysis, technical documentation, project management, LIMS/ERP systems
Preferred skills
operational process improvement, direct client contact experience, troubleshooting assays, data reporting
Technologies
RIA, EIA, Flow Cytometry, Cell-Based Assays, LIMS, ERP, MS Office
Responsibilities
Design, plan, and perform routine and non-routine method development and validation projects; characterize antibodies and perform reagent qualification; develop fit-for-purpose assays; communicate project updates to internal and external clients; provide technical leadership, mentoring, and training to junior staff; organize daily workflow and meet validation timelines; review validation data and reports; troubleshoot assays and provide constructive feedback.
Seniority
Senior, hands-on IC with project leadership
