Bioassay Scientist, Analytical Research & Development
Core
Execute GMP bioassay analysis (ELISA, cell-based) for biologics drug substance and product release, stability, and in-process testing.
Role type
Scientist (R2) Bioassay Analyst
Builds
Biologics Drug Substance and Drug Product
Domain
Biopharmaceuticals / Analytical Research & Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mammalian cell culture, ELISA, Cell-based assays, GMP compliance, SOP adherence, Technical documentation, Project timeline management, Laboratory inventory management
Preferred skills
LIMS, SoftMax Pro, Assay validation, cGxP guidelines, Deviation management, Method development, qPCR, Chromatographic separations
Technologies
SoftMax Pro, LIMS, Electronic notebook
Responsibilities
Validate and implement analytical methods for release and stability testing; Support critical reagent qualifications; Document activities following SOPs; Author and review technical documents; Manage laboratory supplies and critical reagent inventories; Support GMP compliance and continuous improvement of laboratory operations
Seniority
Mid-level, hands-on IC
