Production Head, Isotope Manufacturing (Associate Director)

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis is seeking a Production Head, Isotope Manufacturing, to lead the Indianapolis site and establish a state-of-the-art isotope production operation. You will build high-performing teams, drive operational excellence, and ensure safety, quality and regulatory compliance.

Responsibilities include leading manufacturing operations, audits, and cross-functional collaborations for validation, tech transfers, and product launches while managing budgets and performance to ensure reliable patient

Qualifications

• Experience in pharmaceutical manufacturing operations and regulatory compliance.
• Leadership experience in building high-performing teams.

Responsibilities

• Lead Production and Operations Support to achieve safety, quality, supply, compliance, cost, and people goals.
• Maintain manufacturing operations with cGMP, EHS, radiation safety, and regulatory compliance.
• Coach teams through training, development, and succession planning.
• Drive continuous improvement of processes, staffing, and training systems.
• Review and approve production documentation (SOPs, master batch records, LERs, logbooks).
• Lead investigations and CAPAs for quality events and deviations.
• Prepare for internal audits and Health Authority inspections; ensure document accuracy.
• Partner with cross-functional teams on validation, tech transfers, product launches, and excellence initiatives.
• Manage production performance, budgets, and priorities for reliable patient supply.

Skills

Data Analytics

Education

Bachelor's degree in engineering/chemistry/pharmacy

Job description

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. #LI-Onsite

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.

The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Salary Range $138,600.00 - $257,400.00

Skills Desired Data Analytics

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

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