Bio Bioassay Researcher Candidate Comparison Matrix
Core
Perform laboratory-based experiments and provide scientific support for approved bioassay projects to evaluate biological therapeutics for the FDA.
Role type
Senior IC bioassay researcher
Builds
Validated, reproducible research data for biological therapeutics
Domain
Biopharmaceuticals / Regulatory Science
Deliverable
physical/clinical work
Required skills
mammalian cell culture, in vitro model systems, qRT-PCR, ELISA, western blotting, immunohistochemistry, bioassay design and validation
Preferred skills
transcytosis/permeation assays, polarized epithelial cell layers, air-liquid interface, monoclonal antibodies, inhaled/intranasal therapeutics, FDA/OPQR standards
Technologies
qRT-PCR, ELISA, western blotting, immunohistochemistry
Responsibilities
Culture and maintain immortalized cell lines under air-liquid interface conditions; Optimize transcytosis and permeation bioassays; Validate bioassays for reproducibility, sensitivity, and specificity; Perform hands-on laboratory work using cell culture and analytical techniques; Collect, process, analyze, and document laboratory data; Maintain electronic laboratory notebooks; Report safety incidents and protect government research information.
Seniority
Senior, hands-on IC