Production Head, Isotope Manufacturing (Associate Director)

About the role

Novartis is looking for a Production Head, Isotope Manufacturing (Associate Director) in Indianapolis, Indiana, to lead the establishment and advancement of a state-of-the-art isotope production operation. The role sits at the intersection of advanced science and manufacturing, helping ensure a reliable supply of critical therapies for radioligand treatment. It is an on-site position.

Key responsibilities

• Lead the Production and Operations Support team to meet 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 teams through training, talent development and succession planning.
• Drive continuous improvement of processes, procedures, staffing models and training systems.
• Own, review and approve production documentation such as SOPs, master batch records, executed 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 take part in internal audits and Health Authority inspections, ensuring personnel qualification and accurate, contemporaneous documentation.
• Partner cross-functionally on validation, technology transfers, product launches and operational excellence.
• Manage production performance, budgets and priorities to ensure reliable patient supply.

Required profile

• Bachelor of Science in engineering, chemistry, pharmacy or a related field, or equivalent experience.
• Five or more years in operational roles with direct pharmaceutical manufacturing experience; low bioburden experience preferred.
• Three or more years of leadership experience.
• Experience supporting regulatory inspections by agencies such as the FDA or EMA.
• EHS and GxP/QA experience building an injury- and error-free culture across corporate governance, finance, quality, environment and safety.
• Ability to lead operational excellence, drive continuous improvement and build high-performing teams.

Desirable requirements

• Training in radiochemistry or radiopharmacy.
• Radiation safety education.

What we offer

• Expected salary range of $138,600 to $257,400 per year, with a performance-based cash incentive and possible annual equity awards.
• Health, life and disability benefits, a 401(k) with company contribution and match.
• Vacation, personal days, holidays and other leaves.