Production Head, Isotope Manufacturing (Associate Director)
Core
Lead the establishment and advancement of a state-of-the-art isotope production operation for radioligand therapy manufacturing.
Role type
Associate Director, Production Head
Builds
Isotope production facilities and reliable supply of critical radioligand therapies
Domain
Pharmaceutical manufacturing, Isotope production, Radioligand therapy
Required skills
Pharmaceutical manufacturing operations, cGMP compliance, EHS and radiation safety, Regulatory inspection readiness, Team leadership and development, Process improvement, Documentation management, Root cause analysis
Preferred skills
Radiochemistry or radiopharmacy training, Low bioburden manufacturing experience
Technologies
GxP, EHS systems, Manufacturing execution systems
Responsibilities
Lead production and operations support team to achieve safety, quality, supply, and compliance objectives; Establish and maintain manufacturing operations in full cGMP and radiation safety compliance; Build and coach high-performing teams through training and succession planning; Drive continuous improvement of manufacturing processes and procedures; Own and approve production documentation including SOPs and batch records; Lead investigations and corrective actions for quality events; Prepare for and participate in internal audits and Health Authority inspections; Manage production performance, budgets, and operational priorities.
Seniority
Senior, hands-on IC with leadership mandate