Associate Director - TS/MS - Advanced Therapies Manufacturing
Eli Lilly and Company
August 23, 2026
On-site
Lebanon, IN
Operations
Position Description
The TS/MS Associate Director provides technical and people leadership across Drug Substance and Drug Product processes supporting cGMP late-phase and commercial manufacturing for advanced therapies.
Key Responsibilities/Deliverables
- Lead and promote safety culture; ensure HSE compliance.
- Drive performance management, coaching, and development of TS/MS staff.
- Lead technology transfer of new modalities to the site.
- Develop and execute process and validation strategies; establish robust process control and capability.
- Ensure GMP compliance across documentation (investigations, deviations, change controls, validations, regulatory submissions, annual product reviews, batch records, procedures, control strategies, technical studies).
- Partner cross-functionally to deliver the site technical agenda aligned to business objectives and the GMP Quality Plan.
- Serve as technical representative in regulatory interactions, audits, and external stakeholder engagements.
- Improve process control, robustness, yield, productivity, and manufacturing performance; ensure investigation/product complaint closure.
- Oversee technical projects to improve capability, capacity, quality, and team effectiveness.
- Represent site in the manufacturing network; drive global knowledge sharing and harmonization.
- Support commercialization/technology transfer of new molecule entities; provide oversight at external manufacturing sites.
- Develop and implement site operating systems/processes.
Basic Requirements
- BS/MS in Biochemistry, Biotechnology, Biochemical Engineering, or related.
- 5+ years cGMP commercial manufacturing experience in TS/MS or related (Manufacturing, QC, QA, Engineering).
- 3+ years leading teams.
Additional Preferences
- Experience with AAV and/or mRNA/LNP GMP manufacturing.
- Technical leadership; strong administrative/organizational and people-management skills.
- Proven ability to deliver complex, cross-functional work in fast-paced environments.
- Strong project management, analytical/root-cause skills, communication/influencing.
- Strategic mindset and ability to translate technical/scientific knowledge into practical solutions.
Compensation/Benefits (as stated)
- Anticipated wage: $123,000 - $180,400; may be eligible for a company bonus.
- Eligible benefits include 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
The TS/MS Associate Director provides technical and people leadership across Drug Substance and Drug Product processes supporting cGMP late-phase and commercial manufacturing for advanced therapies.
Key Responsibilities/Deliverables
- Lead and promote safety culture; ensure HSE compliance.
- Drive performance management, coaching, and development of TS/MS staff.
- Lead technology transfer of new modalities to the site.
- Develop and execute process and validation strategies; establish robust process control and capability.
- Ensure GMP compliance across documentation (investigations, deviations, change controls, validations, regulatory submissions, annual product reviews, batch records, procedures, control strategies, technical studies).
- Partner cross-functionally to deliver the site technical agenda aligned to business objectives and the GMP Quality Plan.
- Serve as technical representative in regulatory interactions, audits, and external stakeholder engagements.
- Improve process control, robustness, yield, productivity, and manufacturing performance; ensure investigation/product complaint closure.
- Oversee technical projects to improve capability, capacity, quality, and team effectiveness.
- Represent site in the manufacturing network; drive global knowledge sharing and harmonization.
- Support commercialization/technology transfer of new molecule entities; provide oversight at external manufacturing sites.
- Develop and implement site operating systems/processes.
Basic Requirements
- BS/MS in Biochemistry, Biotechnology, Biochemical Engineering, or related.
- 5+ years cGMP commercial manufacturing experience in TS/MS or related (Manufacturing, QC, QA, Engineering).
- 3+ years leading teams.
Additional Preferences
- Experience with AAV and/or mRNA/LNP GMP manufacturing.
- Technical leadership; strong administrative/organizational and people-management skills.
- Proven ability to deliver complex, cross-functional work in fast-paced environments.
- Strong project management, analytical/root-cause skills, communication/influencing.
- Strategic mindset and ability to translate technical/scientific knowledge into practical solutions.
Compensation/Benefits (as stated)
- Anticipated wage: $123,000 - $180,400; may be eligible for a company bonus.
- Eligible benefits include 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.