Manager, cGMP Manufacturing
Core
Manage cGMP production operations for oncology and cell & gene therapy products, ensuring compliance, team leadership, and on-time delivery.
Role type
Senior manufacturing manager (cGMP)
Builds
Clinical and marketed pharmaceutical products (e.g., RETHYMIC)
Domain
Pharmaceutical manufacturing / Biopharmaceuticals
Required skills
cGMP compliance, team leadership, production scheduling, deviation investigation, CAPA development, root cause analysis, change control management, cleanroom operations, audit preparation
Preferred skills
ISO 7 & 8 cleanroom experience, isolator operation, cell/tissue culture background, aseptic gowning qualification
Technologies
Manufacturing execution systems, cleanroom environments, isolators
Responsibilities
Hire and develop manufacturing team, oversee training and performance, partner with QA for documentation and SOPs, schedule production and emergency work, monitor alarms and respond to issues, participate in audits and FDA inspections, drive continuous improvement initiatives
Seniority
Manager, hands-on leadership