Sterility Assurance Lead - Gene Therapy Manufacturing

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

Benefits offered by this job

401(k) plan

Comprehensive benefits

Job summary

Lilly is building a state-of-the-art gene therapy manufacturing site in Lebanon, Indiana, with a focus on sterility assurance and environmental monitoring. The Sr.

Scientist will lead technical strategies for aseptic processing, cleaning, and contamination risk management to enable compliant start-up and manufacturing. Ideal candidates will have a science degree and 2+ years in cGMP environments, plus proven ability to work across cross-functional teams to drive improvements and regulatory

Qualifications

• Bachelors in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related science discipline.
• 2+ years of experience supporting cGMP manufacturing (environmental monitoring, sterility assurance, microbiology, TS/MS, QA, etc.).
• Authorized to work in the United States full-time; no sponsorship provided.

Responsibilities

• Understand principles for manufacturing gene therapy products, including aseptic processes and sterilization.
• Support sterility assurance programs, including environmental monitoring and process simulations.
• Lead or support investigations and changes related to sterility programs.

Skills

Sterility assurance

Environmental monitoring

Microbiology

Education

Bachelors in Microbiology

Job description

Lilly is building a state-of-the-art gene therapy manufacturing site in Lebanon, Indiana, with a focus on sterility assurance and environmental monitoring. The Sr.

Scientist will lead technical strategies for aseptic processing, cleaning, and contamination risk management to enable compliant start-up and manufacturing. Ideal candidates will have a science degree and 2+ years in cGMP environments, plus proven ability to work across cross-functional teams to drive improvements and regulatory