Sterility Assurance Scientist – Gene Therapy Manufacturing

Eli Lilly and Company; Lebanon (IN); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Paid time off

Job summary

Eli Lilly and Company is seeking a Sr. Scientist - Sterility Assurance to lead and implement sterility programs for a cutting-edge gene therapy manufacturing site in Lebanon, Indiana.

The role focuses on environmental monitoring, aseptic processing, and cleaning/sanitization strategies during facility start-up and ongoing operations. The position requires a Bachelor’s in a related science and 2+ years in cGMP settings, with strong analytical and cross-functional collaboration skills to drive

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related field.
• 2+ years of experience supporting cGMP manufacturing (operations, environmental monitoring, sterility assurance validation, microbiology lab, TS/MS, QA, etc.).
• Authorized to work in the United States full-time; Lilly sponsorship not offered.

Responsibilities

• Understand manufacturing principles for gene therapy products and aseptic processes.
• Evaluate sterility assurance risks and contamination controls.
• Provide technical support for cleaning deviations and root cause analyses.
• Lead start-up activities for sterility programs including environmental monitoring PQ and aseptic simulations.
• Ensure environmental monitoring and sterility programs are followed on the manufacturing floor.
• GuideProcess teams on sterility programs and participate in audits and regulatory inspections.

Skills

Sterility assurance

Environmental monitoring

Root cause analysis

Cross-functional leadership

Data analysis

Education

Bachelor's degree in Microbiology/related

Job description

Eli Lilly and Company is seeking a Sr. Scientist - Sterility Assurance to lead and implement sterility programs for a cutting-edge gene therapy manufacturing site in Lebanon, Indiana.

The role focuses on environmental monitoring, aseptic processing, and cleaning/sanitization strategies during facility start-up and ongoing operations. The position requires a Bachelor’s in a related science and 2+ years in cGMP settings, with strong analytical and cross-functional collaboration skills to drive