Production Head, Isotope Manufacturing (Associate Director)
About The Position
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.
Requirements
- Bachelor of Science degree in engineering, chemistry, pharmacy, or related field, or relevant equivalent experience.
- Five or more years of experience in operational roles with direct experience in pharmaceutical manufacturing; low bioburden manufacturing experience preferred.
- Three or more years of leadership experience.
- Experience supporting regulatory inspections by agencies such as the Food and Drug Administration or European Medicines Agency.
- Environment Health and Safety, and GxP / QA experience building an injury and error-free culture with knowledge of multiple compliance areas (corporate governance, financial, quality, environment, safety).
- Demonstrated ability to lead operational excellence, drive continuous improvement, and build high-performing teams.
Nice To Haves
- Training in radiochemistry or radiopharmacy.
- Radiation safety education.
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.
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- performance-based cash incentive
- eligibility to be considered for annual equity awards
- vacation, personal days, holidays and other leaves
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What This Job Offers
Job Type
Full-time
Career Level
Manager
