Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing

Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing

Position at Lilly, a global healthcare leader headquartered in Indianapolis, Indiana. Lilly unites caring with discovery to make life better for people around the world. Employees worldwide work to discover and bring life‑changing medicines, improve disease understanding and management, and give back through philanthropy and volunteerism. The company is committed to putting people first and looking for individuals determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

Lilly is constructing a cutting‑edge facility for the manufacture of new modalities including Gene Therapy at Lebanon, Indiana. This green‑field site will be Lilly’s most technically advanced manufacturing site focusing on the next wave of innovative products. The Sr. Scientist – Sterility Assurance will help design, commission, and start up the facility for both clinical and commercial supply, owning all areas of technology transfer, process validation, and process stewardship.

• Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of chemistry, equipment, aseptic processes, sanitization, and sterilization.
• Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls regarding potential microbial, endotoxin, and particulate contamination.
• Provide technical support on cleaning deviations/events and assist in root‑cause analysis.
• Support all start‑up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations).
• Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management are followed at the manufacturing floor level.
• Provide technical guidance to the Process Team for sterility assurance programs.
• Lead or support root‑cause investigations related to sterility assurance programs.
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Perform periodic review of environmental monitoring data.
• Lead or support risk assessments related to sterility assurance programs.
• Create, execute, review, and/or approve technical documents related to sterility assurance programs.
• Create, execute, and/or evaluate change controls related to sterility assurance programs.
• Continuously educate self and others to drive improvements and remain current with regulatory expectations and industry trends.
• Participate in continuous improvement projects to improve quality performance at the site.
• Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed.
• Serve as cleaning/sterility assurance interface external to the LP2 site.
• Work within or lead cross‑functional teams to implement TS/MS objectives and deliver on business and quality objectives.
• Ensure a safe working environment through compliance with safety rules and actively participate in safety‑related activities.

• Bachelor’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
• 1+ year of experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation,…