Sr Principal QA Scientist – Radioligand Therapy

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

Job summary

Lilly in Indianapolis is seeking a Sr. Principal Scientist - QA to ensure QA responsibilities support radioligand drug product manufacturing at the IRLT site. You will oversee quality workflows, review batch records in real time, and drive disposition of drug products while maintaining GMP compliance.

You will train floor QA personnel, mentor teams, and collaborate cross-functionally to ensure regulatory readiness and robust QA support for manufacturing and QC operations.

Qualifications

• Bachelor's degree in science, engineering, computer, pharmaceutical-related field.
• 5+ years of experience in QA/QC roles in the pharmaceutical industry.
• On-site role at Indianapolis Radioligand Therapies site.

Responsibilities

• Provide QA oversight during aseptic drug product manufacturing.
• Real-time review of batch records on the floor.
• First line of quality escalation for manufacturing processes and QC operations.
• Disposition of drug product batches and drug substance intermediates.
• Maintain GMP compliance and inspection readiness across operations.
• Provide SME-level training for floor QA and batch QA tasks.

Skills

QA/QC experience

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Quality Management Systems

Inspection readiness

Electronic batch release

Radioligands experience

Education

Bachelor's degree in science/engineering/pharma

Tools

Manufacturing Execution Systems

Electronic batch release

Job description

Lilly in Indianapolis is seeking a Sr. Principal Scientist - QA to ensure QA responsibilities support radioligand drug product manufacturing at the IRLT site. You will oversee quality workflows, review batch records in real time, and drive disposition of drug products while maintaining GMP compliance.

You will train floor QA personnel, mentor teams, and collaborate cross-functionally to ensure regulatory readiness and robust QA support for manufacturing and QC operations.