TS/MS Process Steward - Advanced Therapies Manufacturing
Listed on 2026-06-18
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Engineering
Quality Engineering, Validation Engineer, Process Engineer, Manufacturing Engineer
- Advanced Therapies Manufacturing
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- Advanced Therapies Manufacturing
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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.
Company Overview
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 currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products will include 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.
Position Description
Process Steward – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical ownership and successful execution of the Validation Program at the Lebanon Advanced Therapies (LP2) site. TS/MS Validation personnel provide stewardship of the site’s Validation Program, including assessment of and improvement in existing controls.
The TS/MS Process Steward works with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process.
Key Objectives/Deliverables
- Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization
- Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products
- Write validation protocols and reports in support of the site’s validation programs
- Provide support for other TS/MS related process activities as needed
- Investigate and troubleshoot problems which occur during manufacturing
- Plan and execute validation activities, including cross-functional coordination and internal coordination with Sterility Assurance Scientists
- Prepare and provide technical review of completed/executed validation packages by compiling and analyzing validation data for submission and approval
- Lead resolution of validation deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
- Maintain an up-to-date knowledge of validation requirements, practices, and procedures
- Write validation plans and risk assessments related to specific projects, facilities, products
- Write and review policies and procedures (SOPs)
- Perform risk assessments for validation programs
- Perform and/or coordinate validation studies, testing, verification, and sampling
- Provide technical input for control strategies for the introduction of new products (e.g. CTs), as it relates…
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