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 Radiopharmaceutical Manufacturing)
Builds
Clinical and commercial supply of radiopharmaceutical injectables
Domain
Oncology / Radiopharmaceuticals / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance management, aseptic technique oversight, sterile manufacturing practices, team leadership and development, batch manufacturing scheduling, regulatory guideline adherence (NRC, EH&S, US/EU GMP), KPI monitoring, corrective and preventative action planning
Preferred skills
Radiopharmaceutical manufacturing experience, sterile injectable manufacturing experience
Technologies
GMP documentation systems, batch record software, deviation/CAPA tracking tools
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 are followed; Manage the cleaning and sanitization of the production clean suite; Support investigations and implement corrective and preventative action plans; Monitor and manage production department KPIs related to performance and throughput
Seniority
Manager, hands-on leadership