Night Shift Isotope Production Lead - cGMP & Radiochemistry

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

Benefits offered by this job

Health benefits

401(k) with company match

Generous time off

Job summary

Novartis in Indianapolis is seeking a Production Lead, Isotopes to direct hands-on manufacturing of radiopharmaceutical products. You will mentor technicians, ensure production readiness, and uphold GMP and radiation safety standards in a fast-paced isotope production environment.

The role requires 4+ years of pharma manufacturing, B.S. preferred, and the ability to operate under cGMP and sterile conditions on a 3rd shift (10 pm–6 am). Relocation support is not available.

Qualifications

• Bachelor of Science strongly preferred; without a degree, 2+ years in cGMP/aseptic may substitute.
• 4+ years of pharmaceutical manufacturing experience; low bioburden experience preferred.
• Strong understanding of manufacturing and validation requirements.
• 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, PPE, and respiratory protection equipment (PAPR/respirators).
• Ability to maintain respiratory protection qualifications and perform manufacturing with PPE for extended periods.

Responsibilities

• Execute manufacturing activities for Radioligand Therapy isotope products while 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 material identity and following batch monitoring procedures.
• Complete batch records, shipping documents, training materials, and other production 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

Pharma manufacturing

cGMP

Radiation safety

Team leadership

Quality systems

Education

Bachelor of Science

Tools

MS Office

Job description

Novartis in Indianapolis is seeking a Production Lead, Isotopes to direct hands-on manufacturing of radiopharmaceutical products. You will mentor technicians, ensure production readiness, and uphold GMP and radiation safety standards in a fast-paced isotope production environment.

The role requires 4+ years of pharma manufacturing, B.S. preferred, and the ability to operate under cGMP and sterile conditions on a 3rd shift (10 pm–6 am). Relocation support is not available.