Production Head, Isotope Manufacturing (Associate Director)

Novartis AG; Indiana; On-site; USD 139,000 - 257,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous vacation and leaves

Job summary

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

You will partner across functions to support validation, technology transfers, product launches, and continuous improvement initiatives. A strong background in pharmaceutical manufacturing and leadership is required.

Qualifications

• Five or more years in operational pharmaceutical manufacturing roles.
• Experience supporting regulatory inspections by FDA/EMA is preferred.
• Knowledge of EHS and radiation safety, and compliance programs.

Responsibilities

• Lead Production and Operations teams to meet Safety, Quality, Supply, Compliance, Cost, and People goals.
• Maintain manufacturing operations in full cGMP and regulatory compliance.
• Develop and coach high-performing teams through training and succession planning.
• Drive continuous improvement of processes, staffing models, and training systems.
• Review and approve production docs including SOPs and batch records.
• Lead investigations and CAPAs for quality events and deviations.
• Prepare for internal audits and Health Authority inspections; ensure proper documentation.
• Collaborate across functions on validation, tech transfers, and launches.
• Manage production performance, budgets, and priorities to ensure reliable patient supply.

Skills

Leadership

Regulatory inspections

GxP QA experience

Continuous improvement

Cross-functional collaboration

Education

Bachelor of Science degree in engineering, chemistry, pharmacy, or related field

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.

About the Role

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.

To learn more about the culture, rewards and benefits we offer our people click here.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we'll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.