Specialist, Quality Control Analytical, Cell Therapy (Wednesday -Saturday)
Core
Perform routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products.
Role type
Specialist, Quality Control Analytical
Builds
cGMP-compliant cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Required skills
Flow cytometry, ELISA, PCR, cell culture, cell count/viability, automated cell counting, laboratory instrumentation operation, SOP authoring and review, OOS/OOT investigation, CAPA support, electronic lab notebook management
Preferred skills
Method qualification, peer training, cross-functional collaboration
Technologies
Flow cytometers, ELISA kits, PCR systems, automated cell counters, LIMS
Responsibilities
Execute QC testing per approved methods and SOPs; operate, calibrate, and maintain laboratory instruments; maintain accurate documentation and author/review SOPs; participate in laboratory investigations (OOS/OOT, deviations); complete method qualifications and maintain analyst proficiency; coordinate daily testing priorities and sample receipt.
Seniority
Specialist, hands-on IC