Isotope Production Lead, Night Shift (3rd)

Novartis Group Companies; Indianapolis (IN); On-site; USD 57,000 - 105,000; Full time

Job summary

Novartis Group Companies in Indianapolis, Indiana is seeking a Production Lead, Isotopes to oversee daily manufacturing and mentor technicians. You will ensure GMP compliance, radiation safety, and on-time delivery of isotope products in a hands-on role.

This 3rd shift position (10 pm–6 am, Mon–Fri) requires a strong manufacturing background, ability to lead teams, and a commitment to quality. Relocation support is not available; candidates must be able to work in a controlled cleanroom

Qualifications

• Bachelor of Science strongly preferred; without a degree, a minimum of 2 years in a cGMP or aseptic environment may substitute.
• 4+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing experience preferred.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.
• Ability to lift or carry up to 35 pounds.
• Ability to wear cleanroom garments and respiratory protection equipment as required.

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 procedures and safety requirements.
• Support production readiness through equipment prep, cell cleaning, isolator sterilization, and environmental monitoring.
• Prepare materials while maintaining material identity and following batch monitoring procedures.
• Complete batch records, shipping documents, training materials, and other documentation accurately and compliantly.
• Support qualification and validation activities while promoting GMP compliance and a speak-up culture.
• Ensure technicians complete required training and support their professional development.

Skills

GMP compliance knowledge

Radiation safety awareness

Team leadership

Education

Bachelor of Science preferred

Tools

MS Office

Job description

Novartis Group Companies in Indianapolis, Indiana is seeking a Production Lead, Isotopes to oversee daily manufacturing and mentor technicians. You will ensure GMP compliance, radiation safety, and on-time delivery of isotope products in a hands-on role.

This 3rd shift position (10 pm–6 am, Mon–Fri) requires a strong manufacturing background, ability to lead teams, and a commitment to quality. Relocation support is not available; candidates must be able to work in a controlled cleanroom