Isotope Manufacturing Lead: Operations & Compliance

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

Benefits offered by this job

Performance-based incentive

Equity awards eligibility

Comprehensive benefits package

401(k) with company match

Generous time off

Job summary

Novartis Group of Companies is seeking a Production Head, Isotope Manufacturing, to lead the Indianapolis isotope production operation. You will drive safety, quality, and regulatory compliance while building high-performing teams and ensuring reliable patient supply.

You will oversee cGMP operations, manage budgets, and partner with cross-functional teams on technology transfers, validations, and process improvements. The role requires a strong background in pharma manufacturing and leadership.

Qualifications

• BS degree in engineering, chemistry, pharmacy, or related field.
• 5+ years in operational/pharma manufacturing roles.
• 3+ years of leadership experience.
• Experience supporting FDA/EMA inspections.
• EHS and GxP/QA experience building an injury- and error-free culture.
• Proven track record leading operational excellence.

Responsibilities

• Lead Production and Operations Support to meet site objectives in 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, including SOPs, master batch records, and logbooks.
• Lead investigations, root cause analysis, and corrective actions for quality events and deviations.
• Prepare for and participate in internal audits and Health Authority inspections with proper documentation.
• Collaborate cross-functionally to support validation, technology transfers, product launches, and excellence initiatives.
• Manage production performance, budgets, and priorities to ensure reliable patient supply.

Skills

Data Analytics

Leadership

Regulatory Compliance

Education

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

Job description

Novartis Group of Companies is seeking a Production Head, Isotope Manufacturing, to lead the Indianapolis isotope production operation. You will drive safety, quality, and regulatory compliance while building high-performing teams and ensuring reliable patient supply.

You will oversee cGMP operations, manage budgets, and partner with cross-functional teams on technology transfers, validations, and process improvements. The role requires a strong background in pharma manufacturing and leadership.