Director, LNP/TNP Drug Product Process Development
Eli Lilly and Company
August 12, 2026
On-site
Indianapolis, IN
Operations
Position Summary
Seeking a highly motivated engineer leader for drug product process development of LNP and/or TNP products (from nanoparticle formation to fill/finish) to advance Lilly’s genetic medicine portfolio (Indianapolis; collaboration with Boston).
Responsibilities
- Lead process studies to define clinical and potential commercial manufacturing processes for LNPs/TNPs and other parenteral drug products; mentor junior scientists.
- Lead process development/characterization for new modalities, especially LNPs/TNP late-stage development; assess/mitigate process risks during scale-up using CPPs/CQAs.
- Drive complex tech transfer across sites and internal/external manufacturing; integrate novel excipients into CMC timeline and regulatory submission pathway.
- Collaborate with clinical manufacturing teams and CMOs: author tech transfer documents, review batch records, and provide onsite technical oversight.
- Ensure consistency of technical deliverables/documentation across transfers.
- Represent BR&D on project teams; partner cross-functionally (analytical, quality, supply chain, device delivery, internal/external manufacturing/service) to define drug product/CMC timelines and regulatory deliverables.
- Establish external relationships with academic/industry partners to adopt process technologies.
- Initiate/drive innovation to improve LNP/new modality performance and product quality; present findings to internal/external stakeholders.
Basic Requirements
- Ph.D. (Chemical Engineering or Biomedical Engineering) + minimum 7 years industry experience in LNP/TNP product process development from lipid nanoparticle formation to fill/finish; large-scale clinical-to-commercial preferred.
- Deep experience in lipid/targeted lipid nanoparticle formulation and manufacturing processes.
- Hands-on manufacturing process design/optimization (nanoparticle formation, purification, fill/finish).
- Regulatory submission experience with lipid nanoparticle-based therapies preferred.
- Strong understanding of cGMP, ICH, and regulatory guidelines.
Benefits (explicitly stated)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits.
Physical/Work Environment
- Lab environment; ability to perform essential functions.
Seeking a highly motivated engineer leader for drug product process development of LNP and/or TNP products (from nanoparticle formation to fill/finish) to advance Lilly’s genetic medicine portfolio (Indianapolis; collaboration with Boston).
Responsibilities
- Lead process studies to define clinical and potential commercial manufacturing processes for LNPs/TNPs and other parenteral drug products; mentor junior scientists.
- Lead process development/characterization for new modalities, especially LNPs/TNP late-stage development; assess/mitigate process risks during scale-up using CPPs/CQAs.
- Drive complex tech transfer across sites and internal/external manufacturing; integrate novel excipients into CMC timeline and regulatory submission pathway.
- Collaborate with clinical manufacturing teams and CMOs: author tech transfer documents, review batch records, and provide onsite technical oversight.
- Ensure consistency of technical deliverables/documentation across transfers.
- Represent BR&D on project teams; partner cross-functionally (analytical, quality, supply chain, device delivery, internal/external manufacturing/service) to define drug product/CMC timelines and regulatory deliverables.
- Establish external relationships with academic/industry partners to adopt process technologies.
- Initiate/drive innovation to improve LNP/new modality performance and product quality; present findings to internal/external stakeholders.
Basic Requirements
- Ph.D. (Chemical Engineering or Biomedical Engineering) + minimum 7 years industry experience in LNP/TNP product process development from lipid nanoparticle formation to fill/finish; large-scale clinical-to-commercial preferred.
- Deep experience in lipid/targeted lipid nanoparticle formulation and manufacturing processes.
- Hands-on manufacturing process design/optimization (nanoparticle formation, purification, fill/finish).
- Regulatory submission experience with lipid nanoparticle-based therapies preferred.
- Strong understanding of cGMP, ICH, and regulatory guidelines.
Benefits (explicitly stated)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits.
Physical/Work Environment
- Lab environment; ability to perform essential functions.