Head of Isotope Manufacturing & Operations

Novartis; Indianapolis (IN); On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis is seeking a Production Head, Isotope Manufacturing in Indianapolis to lead a high-performing team responsible for safe, compliant, and efficient production of radioligand therapies. You will shape manufacturing strategy, drive continuous improvement, and ensure reliable patient supply while partnering across functions.

The role emphasizes cGMP operations, radiation safety, and successful collaboration with QA, validation, and technology transfer teams.

Qualifications

• Bachelor of Science degree in engineering, chemistry, pharmacy, or related field, or relevant equivalent experience.
• Five or more years in operational roles with direct pharmaceutical manufacturing experience; low bioburden preferred.
• Three or more years of leadership experience.
• Experience supporting regulatory inspections by FDA/EMA.
• Knowledge of EHS and GxP/QA with strong compliance culture.
• Proven ability to lead operational excellence and build high-performing teams.

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 and succession planning.
• Drive continuous improvement of manufacturing processes, procedures, staffing models, and training systems.
• Own, review, and approve production documentation and records.
• Lead investigations, root cause analysis, and corrective actions for quality events.
• Prepare for and participate in internal audits and Health Authority inspections.
• Partner cross-functionally to support validation, tech transfers, product launches, and operations excellence initiatives.
• Manage production performance, budgets, and priorities to ensure reliable patient supply.

Skills

Leadership

Operational excellence

Cross-functional collaboration

Regulatory inspections

Safety culture

Training & development

Quality mindset

Education

BS in engineering/chemistry/pharmacy

Job description

Novartis is seeking a Production Head, Isotope Manufacturing in Indianapolis to lead a high-performing team responsible for safe, compliant, and efficient production of radioligand therapies. You will shape manufacturing strategy, drive continuous improvement, and ensure reliable patient supply while partnering across functions.

The role emphasizes cGMP operations, radiation safety, and successful collaboration with QA, validation, and technology transfer teams.