Bioanalytical Portfolio Scientist
Core
Technical subject matter expert overseeing outsourced bioanalytical methods and ensuring method validation and performance at CROs for immunogenicity studies.
Role type
Senior IC bioanalytical scientist (outsourced methods oversight)
Builds
Validated immunogenicity assays (ADA, NAb) for biopharmaceutical development
Domain
Biopharmaceuticals / Bioanalysis / Immunogenicity
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method development, method validation, troubleshooting, assay transfer, lifecycle management, regulatory compliance (GLP/GCP), CRO management
Preferred skills
Immunoassay expertise (cell-based/non-cell-based), project management, process planning, issue resolution
Technologies
ADA assays, NAb assays, CRO platforms
Responsibilities
Lead transfer and validation of assays at external CROs; monitor assay performance and provide troubleshooting input; review validation plans, protocols, and reports for scientific accuracy; collaborate with internal experts and CROs on method execution; support supplier evaluation and regulatory activities
Seniority
Senior, hands-on IC
