Director, Process Engineer - Parenteral Drug Product Development
Eli Lilly and Company
August 13, 2026
On-site
Indianapolis, IN
Operations
Overview / Position Summary
The Lilly Bioproduct Research and Development (BR&D) organization supports development and commercialization of parenteral drug products and genetic medicines. Seeking a process engineer leader to advance Lilly’s portfolio from clinical to commercialization in parenteral drug product process development (compounding to fill/finish).
Responsibilities
- Lead scientists to design and execute complex process studies; mentor study design capabilities.
- Design process development and characterization for new modalities and novel drug product presentations; assess/mitigate process risks during scale-up using critical quality attributes (CQAs) and critical process parameters (CPPs).
- Collaborate with internal/external stakeholders to solve tech transfer challenges across sites; integrate novel excipients/technologies into CMC timeline and regulatory submission pathway.
- Support clinical manufacturing at internal and/or external CMOs; author/review tech transfer documents and batch records; provide onsite technical oversight.
- Ensure consistency of technical deliverables/documentation across transfers.
- Represent BR&D on project teams; partner with cross-functional groups (e.g., PM, analytics, quality, device delivery, supply chain, manufacturing) to define drug product/CMC timeline and regulatory deliverables.
- Establish external relationships with academic/industry partners; adopt new process technologies.
- Initiate/drive innovation to improve modality performance and product quality; present findings to internal/external stakeholders.
Basic Requirements
- Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences (highly preferred) and 7+ years industry experience in parenteral drug product process development from bulk compounding to fill/finish.
- Required experience with parenteral process development for peptides, ADCs, fusion proteins, mAbs, and vaccines.
- Required large-scale process development from clinical to commercialization.
- Hands-on design/optimization of manufacturing processes (large-scale compounding, filtration, fill/finish).
- Regulatory submission experience (INDs, NDAs, and/or BLAs).
- Strong cGMP knowledge and familiarity with ICH and regulatory guidelines.
The Lilly Bioproduct Research and Development (BR&D) organization supports development and commercialization of parenteral drug products and genetic medicines. Seeking a process engineer leader to advance Lilly’s portfolio from clinical to commercialization in parenteral drug product process development (compounding to fill/finish).
Responsibilities
- Lead scientists to design and execute complex process studies; mentor study design capabilities.
- Design process development and characterization for new modalities and novel drug product presentations; assess/mitigate process risks during scale-up using critical quality attributes (CQAs) and critical process parameters (CPPs).
- Collaborate with internal/external stakeholders to solve tech transfer challenges across sites; integrate novel excipients/technologies into CMC timeline and regulatory submission pathway.
- Support clinical manufacturing at internal and/or external CMOs; author/review tech transfer documents and batch records; provide onsite technical oversight.
- Ensure consistency of technical deliverables/documentation across transfers.
- Represent BR&D on project teams; partner with cross-functional groups (e.g., PM, analytics, quality, device delivery, supply chain, manufacturing) to define drug product/CMC timeline and regulatory deliverables.
- Establish external relationships with academic/industry partners; adopt new process technologies.
- Initiate/drive innovation to improve modality performance and product quality; present findings to internal/external stakeholders.
Basic Requirements
- Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences (highly preferred) and 7+ years industry experience in parenteral drug product process development from bulk compounding to fill/finish.
- Required experience with parenteral process development for peptides, ADCs, fusion proteins, mAbs, and vaccines.
- Required large-scale process development from clinical to commercialization.
- Hands-on design/optimization of manufacturing processes (large-scale compounding, filtration, fill/finish).
- Regulatory submission experience (INDs, NDAs, and/or BLAs).
- Strong cGMP knowledge and familiarity with ICH and regulatory guidelines.