Drug Substance Manufacturing Scientist - 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.

Description: Drug Substance Manufacturing Scientist - Advanced Therapies Manufacturing role provides technical support for the reliable and compliant manufacture of gene therapy drug substance at external contract manufacturing organizations (CMOs) and, when needed, at LP2, in accordance with global quality standards. This role focuses specifically on drug substance operations — upstream cell culture and bioreactor processes, and downstream purification via chromatography, tangential flow filtration (TFF), and viral filtration. The role requires daily interaction with external partners, internal process teams, and site management, and will lead technology transfer, process validation, process stewardship, and process monitoring activities. A strong understanding of manufacturing principles is required to ensure consistent standards are applied across internal and external manufacturing sites. The role requires cGMP knowledge, familiarity with applicable global regulatory manufacturing guidance, and the ability to work cross-functionally to deliver technical objectives. Key Objectives/Deliverables Maintain in-depth knowledge of the drug substance process and the control strategy for gene therapy products, including cell culture, bioreactor operation, chromatography, TFF, and viral filtration. Provide technical oversight for drug substance manufacturing activities, including technology transfer, process validation, and frontline troubleshooting. Lead resolution of technical issues related to control strategy and manufacturing performance. Build and maintain working relationships with CMO partners and internal technical organizations. Ensure processes are properly characterized, documented, and justified, including alignment of Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) with demonstrated process capability. Monitor processes to confirm they remain compliant, capable, in control, and in a validated or qualified state. Identify early signals of process weakness and proactively resolve or escalate. Initiate deviation records and drive root cause investigations, ensuring on-time closure with appropriate CAPAs and effectiveness checks. Provide technical input to regulatory submissions; author and review annual reports to regulatory agencies. Prepare, review, and approve technical documents, including change controls, validation protocols and summary reports, batch records, process description documents, and annual reports. Maintain a safe working environment through compliance with safety standards and active participation in safety initiatives.

B.S. in Biochemical Engineering,