Production Head, Isotope Manufacturing (Associate Director)
Novartis
Summary
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.
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.
Essential 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.
Desirable Requirements
- Training in radiochemistry or radiopharmacy.
- Radiation safety education.
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
- 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
- Low bioburden manufacturing experience preferred
- Training in radiochemistry or radiopharmacy
- Radiation safety education
Benefits
- Health benefits
- Life insurance
- Disability benefits
- 401(k) with company contribution and match
- Performance-based cash incentive
- Annual equity awards
- Vacation
- Personal days
- Holidays
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.