Sterility Assurance Scientist – Gene Therapy Manufacturing

BioSpace; Lebanon (IN); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Vacation benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Sr. Scientist - Sterility Assurance to lead start-up and ongoing sterility programs at the Lebanon, Indiana site for gene therapy manufacturing. The role emphasizes environmental monitoring, aseptic processing, and risk management to ensure compliant production.

You will design, implement, and optimize sterility strategies, supervise cross-functional teams, and drive continuous improvement with safety and regulatory readiness in mind.

Qualifications

• Bachelor's degree in a relevant science field (Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related).
• 2+ years in support of cGMP manufacturing (environmental monitoring, sterility assurance, microbiology, TS/MS, QA).
• Authorized to work in the United States full-time; Lilly does not provide sponsorship.

Responsibilities

• Develop and implement sterility assurance initiatives for gene therapy manufacture.
• Provide technical leadership on environmental monitoring strategies and aseptic processes.
• Support start-up activities including decontamination evaluations and PQ.
• Ensure sterility programs are followed on the manufacturing floor.
• Lead investigations related to sterility issues and drive corrective actions.

Skills

Sterility assurance

Environmental monitoring

cGMP manufacturing

Root cause analysis

Data trending

Education

Bachelor's in Microbiology or related field

Tools

Statistical analysis

Environmental monitoring equipment

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a Sr. Scientist - Sterility Assurance to lead start-up and ongoing sterility programs at the Lebanon, Indiana site for gene therapy manufacturing. The role emphasizes environmental monitoring, aseptic processing, and risk management to ensure compliant production.

You will design, implement, and optimize sterility strategies, supervise cross-functional teams, and drive continuous improvement with safety and regulatory readiness in mind.