GeneFab: Specialized contract manufacturing for advanced cell and gene therapies.
10+ YOEBachelor's degree preferred in science, 10+ years in compliance, quality, and CDMO/CMO management, 10+ years GMP/QA experience, and knowledge of FDA, EMA, ICH, and international biopharma regulations.
Nova Pneuma: Developing rapid-onset inhaled medicines for acute therapeutic needs.
15+ YOE8+ MgmtBachelor's degree in a scientific field or equivalent experience; 15+ years in senior regulatory and QA/QC roles, including 8+ years at executive level; FDA and international inspection leadership experience.
Quality Management System (QMS), CAPA, FDA, EMA, ICH, cGMP, GLP, GCP, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 820, ISO 13485, EU MDR 2017/745