San Diego, California24 days ago
Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy analytical/molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for process monitoring and product release and stability, e.g., compendial methods, HPLC, DLS, droplet digital PCR or qPCR, ELISA, and cell based potency assays. · Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role.