Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

The Sr. Scientist - Sterility Assurance – Technical Services/Manufacturing Scientist (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies. Primary objectives include the start-up and compliant manufacturing of gene therapy drug product and drug substance, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management. Key Objectives/Deliverables Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, sanitization, and sterilization. Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Provide technical support on cleaning deviations/events and assist in root cause analysis. Provide technical support for 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, etc.) Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level Provide technical guidance to the Process Team for sterility assurance programs Lead or provide technical support for 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 Continually educate self and others to drive improvements and to remain