Isotope Production Lead - 3rd Shift

Novartis AG; Indianapolis (IN); On-site; USD 56,000 - 105,000; Full time

Job summary

Novartis AG in Indianapolis, IN, is seeking a Production Lead, Isotopes, to oversee daily manufacturing of radioligand therapy isotope products on a 3rd shift (10 pm–6 am). The role emphasizes safety, quality, and teamwork, with mentoring of technicians and cross-functional collaboration.

The ideal candidate has a science background and 4+ years in pharma manufacturing, with cGMP and radiation safety experience. Role requires lifting up to 35 lb and PPE use, including PAPR.

Qualifications

• Bachelor's degree preferred; if no degree, 2 years cGMP/aseptic experience may substitute.
• 4+ years in pharmaceutical manufacturing; low bioburden experience preferred.
• Strong understanding of cGMP and FDA guidance for isotope manufacturing.
• Proficient in MS Office.

Responsibilities

• Execute manufacturing activities for Radioligand Therapy isotope products meeting production, quality, and radiation safety requirements.
• Operate and maintain Grade C isolators per procedures and safety requirements.
• Support production readiness through equipment prep, cell cleaning, isolator sterilization, and environmental monitoring.
• Prepare materials while maintaining identity and following batch monitoring procedures.
• Complete batch records, shipping docs, training materials, and other production documentation compliantly.
• Support qualification/validation activities and promote GMP compliance and speak-up culture.
• Ensure technicians complete required training and support their development.

Skills

Data Analytics

MS Office

Team Leadership

Education

Bachelor of Science

Tools

MS Office

Job description

Novartis AG in Indianapolis, IN, is seeking a Production Lead, Isotopes, to oversee daily manufacturing of radioligand therapy isotope products on a 3rd shift (10 pm–6 am). The role emphasizes safety, quality, and teamwork, with mentoring of technicians and cross-functional collaboration.

The ideal candidate has a science background and 4+ years in pharma manufacturing, with cGMP and radiation safety experience. Role requires lifting up to 35 lb and PPE use, including PAPR.