Senior/Principal Scientist Cell Based Potency Assay
Core
Develop, validate, and manage cell-based potency assays and functional bioassays for biologics, vaccines, and cell/gene therapies to support product characterization, GMP release, stability testing, and regulatory submissions.
Role type
Senior/Principal Scientist, Cell-Based Potency Assay Development
Builds
Cell-based potency assays, functional bioassays, and analytical control strategies for biologics programs
Domain
Biopharmaceuticals / Biologics / Analytical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mammalian cell culture, cell-based potency assay development, functional bioassay design, statistical analysis (dose-response modeling, relative potency), assay validation and qualification, troubleshooting complex assays, regulatory documentation (CMC), cross-functional technical leadership
Preferred skills
mechanism-of-action-driven analytical methods, assay automation and data visualization, patent-related contributions, publication of technical results
Technologies
luminescence, fluorescence, absorbance, ELISA, MSD, flow cytometry, reporter assays, neutralization assays, ELN/LIMS
Responsibilities
Lead design, execution, and analysis of potency assay development and lifecycle management studies; Translate mechanism of action into biologically relevant assay formats; Provide technical leadership for assay workstreams and cross-functional teams; Lead statistical analysis including dose-response modeling and acceptance criteria establishment; Troubleshoot complex assay and cell culture issues; Lead internal and external assay transfer activities; Prepare technical documentation for regulatory submissions and SOPs
Seniority
Senior/Principal, hands-on IC with technical leadership
