Director, LNP/TNP Drug Product Process Development
Eli Lilly and Company
September 02, 2026
On-site
Indianapolis, IN
Operations
Position Summary:
Seeking a highly motivated engineer leader with extensive industry experience in drug product process development of LNP and/or TNP products from nanoparticle formation to fill/finish to advance Lilly’s genetic medicine programs. Located at Lilly’s tech center in Indianapolis; collaborates with Boston and Indianapolis sites.
Responsibilities:
- Lead process-study design and execution to define clinical and potential commercial manufacturing processes for LNPs/TNPs and other parenteral drug products; mentor junior scientists.
- Drive process development and characterization of new modalities, especially LNPs/TNP late-stage development; assess/mitigate process risks during scale-up using CQAs/CPPs.
- Lead complex tech transfer across sites and internal/external manufacturing; integrate novel excipients into CMC timelines and support regulatory submission pathway.
- Support clinical manufacturing at internal and/or external CMOs; author tech transfer documents, review batch records, and provide onsite oversight for manufacturing technical hurdles.
- Ensure consistency of technical deliverables and documentation across transfers.
- Cross-functional representation on project teams to define drug product/CMC timeline and key deliverables for regulatory submission.
- Build strategic relationships with academic/industry partners to adopt new process technologies.
- Initiate/drive innovation in LNP/new modality process performance and product quality; present findings internally/externally.
Basic Requirements:
- Ph.D. in Chemical Engineering or Biomedical Engineering; 7+ years industry experience in LNP/TNP product process development from lipid nanoparticle formation to fill/finish. Large-scale clinical-to-commercial experience preferred.
- Deep expertise in lipid/targeted lipid nanoparticle formulation and manufacturing processes.
- Hands-on manufacturing process design/optimization (nanoparticle formation, purification, fill/finish).
- Regulatory submission knowledge for lipid nanoparticle-based therapies preferred.
- Strong understanding of cGMP and ICH/regulatory guidelines.
Benefits:
- Full-time employees may be eligible for a company bonus and a comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life/death benefits, time off/leave, and well-being benefits.
Application Instructions:
- N/A
Seeking a highly motivated engineer leader with extensive industry experience in drug product process development of LNP and/or TNP products from nanoparticle formation to fill/finish to advance Lilly’s genetic medicine programs. Located at Lilly’s tech center in Indianapolis; collaborates with Boston and Indianapolis sites.
Responsibilities:
- Lead process-study design and execution to define clinical and potential commercial manufacturing processes for LNPs/TNPs and other parenteral drug products; mentor junior scientists.
- Drive process development and characterization of new modalities, especially LNPs/TNP late-stage development; assess/mitigate process risks during scale-up using CQAs/CPPs.
- Lead complex tech transfer across sites and internal/external manufacturing; integrate novel excipients into CMC timelines and support regulatory submission pathway.
- Support clinical manufacturing at internal and/or external CMOs; author tech transfer documents, review batch records, and provide onsite oversight for manufacturing technical hurdles.
- Ensure consistency of technical deliverables and documentation across transfers.
- Cross-functional representation on project teams to define drug product/CMC timeline and key deliverables for regulatory submission.
- Build strategic relationships with academic/industry partners to adopt new process technologies.
- Initiate/drive innovation in LNP/new modality process performance and product quality; present findings internally/externally.
Basic Requirements:
- Ph.D. in Chemical Engineering or Biomedical Engineering; 7+ years industry experience in LNP/TNP product process development from lipid nanoparticle formation to fill/finish. Large-scale clinical-to-commercial experience preferred.
- Deep expertise in lipid/targeted lipid nanoparticle formulation and manufacturing processes.
- Hands-on manufacturing process design/optimization (nanoparticle formation, purification, fill/finish).
- Regulatory submission knowledge for lipid nanoparticle-based therapies preferred.
- Strong understanding of cGMP and ICH/regulatory guidelines.
Benefits:
- Full-time employees may be eligible for a company bonus and a comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life/death benefits, time off/leave, and well-being benefits.
Application Instructions:
- N/A