Expert/Senior* Expert Gene Therapy Analytical Development - Bioassay
Core
Develop and validate analytical methods (cell-based and plate-based assays) to characterize gene therapy products for clinical and commercial manufacturing.
Role type
Senior IC analytical development scientist (gene therapy bioassays)
Builds
Gene therapy drug substances and products
Domain
Biopharmaceuticals / Gene Therapy
Required skills
Analytical method development and validation, Cell-based assay design, Plate-based assay execution (ELISA, MSD, high-content imaging, luminescent/fluorescent readers), GMP/GLP compliance, Technical writing (SOPs, validation reports), Project management, Equipment qualification
Preferred skills
AAV/LV vector analytics, AI in daily activities, Experience with PCR, Flow cytometry
Technologies
ELISA, MSD, High-content imaging, Luminescent/fluorescent plate readers, PCR, Flow cytometry
Responsibilities
Design, plan, and perform product characterization studies; Identify, develop, and validate novel analytical assays; Author and review method development and validation reports; Maintain and qualify lab equipment; Drive project timelines and deliverables; Implement solutions to technical challenges
Seniority
Senior, hands-on IC