Scientist, Analytical Development
Core
Develop, optimize, and qualify analytical methods for characterizing bioprinted tissue therapeutics, including raw materials, in-process samples, and final drug products.
Role type
Senior IC analytical development scientist (cell/gene therapy)
Builds
Analytical methods and data supporting product characterization and stability testing for bioprinted tissue therapeutics
Domain
Biotechnology / Advanced therapies (cell therapy, gene therapy, combination products)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, Flow cytometry, ELISA, Cell-based assays, GxP compliance (GLP/GMP), Regulatory validation (ICH/FDA/EMA/Health Canada), Troubleshooting, SOP authoring, Data integrity
Preferred skills
Experience in biotechnology or pharmaceutical industry, Hands-on experience in cell therapy or gene therapy, Continuous improvement mindset
Technologies
Flow cytometry, ELISA, Cell-based assays
Responsibilities
Design and execute analytical methods for characterization, release, and stability testing; Qualify and validate methods per regulatory guidelines; Perform routine analytical testing and instrument maintenance; Author technical reports, protocols, and SOPs; Troubleshoot method issues and implement corrective actions; Collaborate cross-functionally with Process Development, QC, R&D, and Manufacturing
Seniority
Mid-Senior, hands-on IC
