Manager, Quality Control Bioassay

Role: Manager, Quality Control - Bioassay at a biopharma company focused on gene therapy. Responsibilities: oversee cell-based potency, protein chemistry, and molecular biology assays (e.g., ddPCR, qPCR, SDS-PAGE, western blot) for process monitoring, stability, and release in GMP setting; manage routine testing, data review, assay transfer/validation, and author SOPs; support method transfer with CDMOs; perform QMS activities including deviation and CAPA investigations; maintain lab equipment and track samples using LIMS; supervise QC staff. Requirements: Bachelor’s degree with 7+ years (or MS with 5+ years) relevant GMP experience; strong background in analytical method development and validation, especially in cell-based potency and molecular assays; familiar with instrumentation such as droplet digital PCR and cell counters; experience in biologics or gene therapy QC environments. Preferred: familiarity with JMP software. Work setup: full-time, on-site in San Diego; minimal travel. High-value specifics: GMP QC testing, gene therapy (AAV-based) lab, assay transfer and validation, analytical method lifecycle management.