Regulatory Bioassay Research Scientist
Core
Lead research projects to develop, validate, and implement cell-based bioassays for biotechnology products (biosimilars) and complex generics to support regulatory decisions.
Role type
Regulatory Bioassay Research Scientist
Builds
Validated cell-based assays for therapeutic proteins and peptides
Domain
Biopharmaceuticals / Bioassay Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Cell-based assay development, mammalian cell culture, aseptic techniques, bioanalytical instrumentation operation, RNA extraction, protein preparation, western-blot analysis, cytokine/hormone measurement, data analysis, scientific writing, GLP/ISO practices
Preferred skills
Biopharmaceutical manufacturing knowledge, insulin and GLP1-R signaling pathway expertise, potency bioassay development
Technologies
Plate readers, bioanalytical analyzers, data management systems
Responsibilities
Perform cell-based assays for therapeutic proteins or peptides, operate and maintain laboratory instrumentation, culture mammalian cells using aseptic techniques, perform characterization analyses (RNA extraction, western-blot, cytokine measurement), establish new analytical methods, collect and process sample information, prepare analysis and status reports, conduct weekly meetings with program lead, provide monthly status reports to stakeholders
Seniority
Mid-level, hands-on IC
