Director- Purification- Process Translation and Execution
Eli Lilly and Company
August 11, 2026
On-site
Lebanon, IN
Operations
Position Summary
- Lead and grow the PTE (Process Translation and Execution) group; shape a high-performing team and drive clinical pipeline delivery across modalities.
Key Responsibilities
Team Leadership and Development
- Lead, mentor, and develop PTE scientists in downstream bioprocessing (chromatography, TFF/UFDF, viral inactivation, viral filtration) across biologics and mixed modalities.
- Provide coaching, one-on-ones, and performance feedback; promote psychological safety and professional growth.
Technology Transfer and GMP Production Support
- Oversee clinical DS purification/conjugation technology transfers to Foundry cGMP; lead fit assessments, risk analyses, and scale-up strategy for right-first-time execution.
- Serve as primary SME on the manufacturing floor; lead deviation investigations, root cause analysis, and CAPAs to closure.
- Streamline tech transfer, accelerate timelines, and digitize technical documentation/workflows.
- Ensure processes remain compliant, capable, and qualified; support tech transfer for commercialization.
Site Technology Strategy and Innovation
- Define and lead purification/conjugation technology strategy; industrialize next-generation capabilities.
- Guide/support CAPEX to align capabilities with portfolio demands.
Cross-Functional Collaboration and Influence
- Liaison across Process Development/Engineering, Analytical, Quality, Supply Chain, HSE, and Operations.
- Represent PTE in regulatory inspections/audits.
- Build external partnerships.
Basic Qualifications
- PhD in Biology/Biochemistry/Bioengineering/Chemical Engineering or related.
- 12+ years biologics DS development/manufacturing; 8+ years purification process experience.
- Expertise in downstream unit operations (chromatography; TFF/UFDF; viral inactivation; viral filtration), column packing/resin management, and scaling to clinical scale.
- Proven experience leading/coaching direct reports.
Additional Skills/Preferences
- Bioconjugation (ADC/ARC or related), conjugation optimization, DAR control; post-conjugation purification (including organic solvent handling at moderate scale).
- Single-use downstream systems (e.g., skids, SUMs, single-use TFF) and PCC/continuous chromatography.
- PAT knowledge (inline UV, conductivity, pressure).
- Process innovation/continuous improvement; complex deviations/RCA/CAPA.
- Emerging purification modalities (e.g., mRNA, LNP downstream, novel affinity ligands); strong cGMP/quality/regulatory knowledge.
- Strong communication and conflict resolution; team-building.
Compensation and Benefits
- Anticipated wage: $151,500–$264,000.
- Eligible for company bonus and comprehensive benefits (e.g., 401(k), pension, medical/dental/vision, life insurance, time off, well-being benefits) if applicable.
- Lead and grow the PTE (Process Translation and Execution) group; shape a high-performing team and drive clinical pipeline delivery across modalities.
Key Responsibilities
Team Leadership and Development
- Lead, mentor, and develop PTE scientists in downstream bioprocessing (chromatography, TFF/UFDF, viral inactivation, viral filtration) across biologics and mixed modalities.
- Provide coaching, one-on-ones, and performance feedback; promote psychological safety and professional growth.
Technology Transfer and GMP Production Support
- Oversee clinical DS purification/conjugation technology transfers to Foundry cGMP; lead fit assessments, risk analyses, and scale-up strategy for right-first-time execution.
- Serve as primary SME on the manufacturing floor; lead deviation investigations, root cause analysis, and CAPAs to closure.
- Streamline tech transfer, accelerate timelines, and digitize technical documentation/workflows.
- Ensure processes remain compliant, capable, and qualified; support tech transfer for commercialization.
Site Technology Strategy and Innovation
- Define and lead purification/conjugation technology strategy; industrialize next-generation capabilities.
- Guide/support CAPEX to align capabilities with portfolio demands.
Cross-Functional Collaboration and Influence
- Liaison across Process Development/Engineering, Analytical, Quality, Supply Chain, HSE, and Operations.
- Represent PTE in regulatory inspections/audits.
- Build external partnerships.
Basic Qualifications
- PhD in Biology/Biochemistry/Bioengineering/Chemical Engineering or related.
- 12+ years biologics DS development/manufacturing; 8+ years purification process experience.
- Expertise in downstream unit operations (chromatography; TFF/UFDF; viral inactivation; viral filtration), column packing/resin management, and scaling to clinical scale.
- Proven experience leading/coaching direct reports.
Additional Skills/Preferences
- Bioconjugation (ADC/ARC or related), conjugation optimization, DAR control; post-conjugation purification (including organic solvent handling at moderate scale).
- Single-use downstream systems (e.g., skids, SUMs, single-use TFF) and PCC/continuous chromatography.
- PAT knowledge (inline UV, conductivity, pressure).
- Process innovation/continuous improvement; complex deviations/RCA/CAPA.
- Emerging purification modalities (e.g., mRNA, LNP downstream, novel affinity ligands); strong cGMP/quality/regulatory knowledge.
- Strong communication and conflict resolution; team-building.
Compensation and Benefits
- Anticipated wage: $151,500–$264,000.
- Eligible for company bonus and comprehensive benefits (e.g., 401(k), pension, medical/dental/vision, life insurance, time off, well-being benefits) if applicable.