Manager, Production
Core
Lead the day-to-day oversight, execution, and leadership of the drug product manufacturing team for radiopharmaceutical injectables at clinical and commercial scale.
Role type
Manager, Production (GMP Radiopharmaceuticals)
Builds
Clinical and commercial supply of radiopharmaceutical injectables
Domain
Biopharmaceuticals / Oncology / Radiopharmaceuticals
Required skills
GMP compliance, aseptic technique, sterile manufacturing, batch manufacturing, team leadership, regulatory standards, KPI management, corrective action planning
Preferred skills
Radiopharmaceutical experience, sterile injectable manufacturing experience, AI application for team execution
Technologies
GMP documentation systems, batch record systems, CAPA systems
Responsibilities
Provide in-plant management of production personnel and ensure GMP compliance; Oversee daily production schedules and batch manufacturing; Ensure aseptic technique and sterile manufacturing practices; Manage cleaning and sanitization of the production clean suite; Support operator qualification program development; Draft GMP documentation (Batch Records, SOPs, Deviations, CAPAs); Support investigations and implement corrective actions; Monitor and manage production department KPIs; Ensure compliance with NRC, EH&S, and US/EU GMP guidelines.
Seniority
Manager, hands-on leadership