Senior QA Scientist — Onsite Radioligand GMP

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

Benefits offered by this job

401(k) match

Medical benefits

Vacation benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Sr. Principal Scientist - QA to provide quality assurance oversight for radioligand drug product manufacturing at the Indianapolis Radioligand Therapies site.

The role emphasizes on-floor QA, batch disposition, and real-time review of records in a GMP environment. Responsibilities include training, deviation management, and cross-functional collaboration to maintain inspection readiness and high-quality manufacturing standards.

Qualifications

• Bachelor's degree or equivalent in science/engineering/pharma.
• 5+ years of QA/QC experience in pharma industry.
• On-site role at Indianapolis Radioligand Therapies site.

Responsibilities

• Provide on-floor QA oversight during aseptic drug product manufacturing.
• Review batch records in real time and support quality escalations.
• Ensure batch disposition meets requirements prior to release.
• Lead quality reviews of deviations, changes, and procedures.
• Train floor QA personnel as SME and trainer for QA tasks.
• Support development of site quality processes and procedures.

Skills

QA/QC experience

GMP knowledge

Regulatory readiness

Cross-functional teamwork

Radioligand experience

Education

Bachelor's degree in science/engineering/pharma

Tools

LIMS

Electronic batch release

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a Sr. Principal Scientist - QA to provide quality assurance oversight for radioligand drug product manufacturing at the Indianapolis Radioligand Therapies site.

The role emphasizes on-floor QA, batch disposition, and real-time review of records in a GMP environment. Responsibilities include training, deviation management, and cross-functional collaboration to maintain inspection readiness and high-quality manufacturing standards.