About the role
Band
Level 5
Job Description Summary
Location: Indianapolis, Indiana, USA
Imagine leading the future of radioligand therapy manufacturing and helping deliver life-changing treatments to patients around the world. As Production Head, Isotope Manufacturing, you will play a pivotal leadership role in establishing and advancing a state-of-the-art isotope production operation in Indianapolis. This is a unique opportunity to build high-performing teams, shape manufacturing excellence, drive operational performance, and foster a culture of safety, quality, compliance, and innovation. Working at the intersection of cutting-edge science and advanced manufacturing, you will help ensure the reliable supply of critical therapies while influencing the future growth of Novartis' radioligand therapy network.
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Job Description
Key Responsibilities
- Lead the Production and Operations Support team to achieve site objectives for Safety, Quality, Supply, Compliance, Cost, and People.
- Establish and maintain manufacturing operations in full cGMP, EHS, radiation safety, and regulatory compliance.
- Build, develop, and coach high-performing teams through training, talent development, and succession planning.
- Drive continuous improvement of manufacturing processes, procedures, staffing models, and training systems.
- Own, review, and approve production documentation, including Standard Operating Procedures, master batch records, executed production records, logbooks, work orders, technical assessments, and white papers.
- Lead investigations, root cause analysis, and corrective actions for quality events and manufacturing deviations.
- Prepare for and participate in internal audits and Health Authority inspections; ensure personnel qualification and complete, accurate, and contemporaneous documentation of manufacturing activities.
- Partner cross-functionally to support validation, technology transfers, product launches, and operational excellence initiatives.
- Manage production performance, budgets, and operational priorities to ensure reliable patient supply.