Isotope Production Lead – 3rd Shift (GMP)

Novartis; Indianapolis (IN); On-site; USD 85,000 - 159,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time off

Job summary

Novartis is seeking a Production Lead, Isotopes in Indianapolis to oversee day-to-day manufacturing of Radioligand Therapy isotope products. You will guide technicians, ensure production readiness, and uphold radiation safety and GMP standards in a hands-on role during a 10pm–6am shift.

You will collaborate with cross-functional teams to drive quality culture, enable continuous improvement, and maintain regulatory compliance while developing staff and sustaining production metrics.

Qualifications

• Bachelor of Science preferred; without a degree, a minimum of 2 years of experience in a cGMP or aseptic environment may substitute.
• 4+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing experience preferred.
• Strong understanding of manufacturing and validation requirements and activities.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.

Responsibilities

• Execute manufacturing activities for Radioligand Therapy isotope products while meeting production, quality, and radiation safety requirements.
• Operate and maintain Grade C isolators in accordance with established procedures and applicable safety requirements.
• Support production readiness through equipment preparation, cell cleaning, isolator sterilization, and environmental monitoring.
• Prepare materials while maintaining material identity and following established batch monitoring procedures.
• Complete batch records, shipping documents, training materials, and other required production documentation accurately and compliantly.
• Support qualification and validation activities while promoting current GMP compliance and a speak‑up culture.
• Ensure technicians complete required training and support their professional development to foster a strong growth culture.

Skills

Data Analytics

Education

Bachelor of Science (BS) preferred

Tools

MS Office

Job description

Novartis is seeking a Production Lead, Isotopes in Indianapolis to oversee day-to-day manufacturing of Radioligand Therapy isotope products. You will guide technicians, ensure production readiness, and uphold radiation safety and GMP standards in a hands-on role during a 10pm–6am shift.

You will collaborate with cross-functional teams to drive quality culture, enable continuous improvement, and maintain regulatory compliance while developing staff and sustaining production metrics.