Senior QA Scientist, Radioligand Therapy Ops

BioSpace; Indianapolis (IN); On-site; USD 66,000 - 172,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, invites experienced QA professionals to join the Radioligand Therapies QA team. The Sr.

Principal Scientist - QA will provide quality oversight for aseptic drug product manufacturing, conduct real-time batch record reviews, and ensure disposition compliance for drug products at the Indianapolis Radioligand Therapies site. The role emphasizes on-site presence across manufacturing areas, ensuring GMP compliance, inspection readiness, and collaboration

Qualifications

• Bachelor's degree in science, engineering, computer, pharmaceutical-related field of study or related technical degree.
• 5+ years of experience in QA/QC roles in the pharmaceutical industry.
• On-site role (Indianapolis Radioligand Therapies).
• Authorized to work in the United States on a full-time basis; no visa sponsorship provided.

Responsibilities

• Provide QA oversight for radioligand drug product manufacturing and real-time batch record review.
• Support QA Ops in safety and quality during manufacturing activities.
• Ensure batch disposition includes deviations, changes, and documentation.
• Disposition of Drug product batches and Drug substance intermediates.
• Maintain GMP compliance and inspection readiness on the floor and in QA processes.
• Plan and schedule qualification/requalification activities.
• Train floor QA and batch QA personnel as SME and trainer.
• Review manufacturing documentation (deviations, changes, procedures, training docs, method validations).
• Support site readiness plans and development of quality processes.

Skills

Attention to detail

Independent worker

Cross-functional collaboration

Communication skills

Problem-solving

Education

Bachelor's degree in science/engineering/pharma or related technical field

Tools

Manufacturing Execution Systems

Electronic batch release

Job description

Lilly, headquartered in Indianapolis, Indiana, invites experienced QA professionals to join the Radioligand Therapies QA team. The Sr.

Principal Scientist - QA will provide quality oversight for aseptic drug product manufacturing, conduct real-time batch record reviews, and ensure disposition compliance for drug products at the Indianapolis Radioligand Therapies site. The role emphasizes on-site presence across manufacturing areas, ensuring GMP compliance, inspection readiness, and collaboration