Lilly
Healthcare
AssociateScientist-ProcessDevelopment
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Associate Scientist - Process Development at Lilly. Skills: Downstream purification, Viral vector programs, Process development. Lead development, optimization, and scale-up of downstream purification. Design and implement purification strategies using Iodixanol and”
Industry & Context.
Troubleshooting; Process characterization; Process robustness studies; Data analysis; Result interpretation
What They're Looking For.
Must Have
Master's degree in biology, biochemistry, chemical engineering, biotechnology or related field, 8+ years of relevant downstream process development experience in industry, Authorized to work in the United States on a full-time basis
Nice to Have
CsCl and iodixanol ultracentrifugation, Affinity chromatography, Ion-exchange chromatography, TFF/UFDF operations including concentration, diafiltration, and formulation development, AKTA systems and Unicorn software, Process scale-up, platform development, and purification process characterization, Analyzing purification performance and product quality attributes using relevant analytical methods, AAV downstream process development and capsid enrichment workflows, Automated chromatography systems and process intensification strategies, Supporting technology transfer and manufacturing readiness activities, Familiarity with GMP development environments and regulatory expectations
What You'll Do.
and scale-up of downstream purification
Design and implement purification strategies using Iodixanol and
Design and implement affinity chromatography
Design and implement ion-exchange chromatography (AEX/CEX)
Design and implement membrane chromatography
Design and implement polishing operations
Lead AKTA-based chromatography workflow development
Lead process intensification initiatives
Develop scalable downstream platform approaches
Support rapid material generation
Support process consistency across programs
Independently design experiments
Present technical conclusions to multi-functional teams and leadership
Drive troubleshooting
Drive process characterization
Drive process robustness studies
Collaborate closely with upstream
Support program deliverables and timelines
Support technology transfer
Support process documentation
Support development reports
Lead development and optimization of TFF/UFDF workflows
Optimize workflows for concentration
Optimize workflows for buffer exchange
Optimize workflows for formulation
Optimize workflows for process scalability
Mentor junior scientists/engineers
Provide technical guidance across purification activities
Contribute to implementation of new purification technologies
Contribute to implementation of automation tools
Contribute to implementation of continuous process improvements
Ensure compliance with safety standards
Ensure compliance with documentation standards
Ensure compliance with quality standards
How You'll Work.
Team & Collaboration
Multi-functional teams; Upstream, analytical, manufacturing; External partners
Communication Scope
Present technical conclusions
Process & Methodology
Process development strategies, Platform development initiatives, Technology implementation
Full Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. We are seeking a highly motivated Principal Engineer to join the Downstream Process Development team. The successful candidate will lead development and optimization of downstream purification processes supporting viral vector programs from research through preclinical development. The ideal candidate will possess deep technical expertise in downstream purification technologies including ultracentrifugation, chromatography, and tangential flow filtration (TFF), with demonstrated experience driving process development strategies, platform development initiatives, technology implementation, and multi-functional collaboration. This role requires strong scientific leadership, hands-on technical capability, and the ability to independently lead complex purification development activities in a fast-paced environment. **Key Responsibilities** * Lead development, optimization, and scale-up of downstream purification workflows for viral vectors. * Design and implement purification strategieusingng Iodixanol and CsCl density gradient ultracentrifugation, affinity chromatography, ion-exchange chromatography (AEX/CEX), membrane chromatography, and polishing operations. * Lead AKTA-based chromatography workflow development and process intensification initiatives. * Develop scalable downstream platform approaches to support rapid material generation and process consistency across programs. * Independently design experiments, analyze data, i
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