Senior Scientist -Technical Services, Downstream Process Improvement
Elanco
August 25, 2026
On-site
Indianapolis, IN
Operations
Senior Scientist, Downstream Process Development / Optimization
Responsibilities:
- Lead downstream process unit operation improvement programs for manufactured biologics, developing and optimizing purification processes using phase-appropriate strategies and QbD principles.
- Design and execute bench- and pilot-scale studies, including scale-down model development, process scale-up, and providing manufacturing support.
- Support risk assessments, control strategy development, stage-gate reviews, and technical decision-making for biologic drug substance programs.
- Author and review technical reports, process development documents, tech transfer packages, and CMC regulatory submissions; support responses to regulatory agencies.
- Partner with R&D, MS&T, Manufacturing, Quality, and external CDMOs to ensure successful tech transfer and adoption of process improvements as a downstream process development SME.
Minimum Qualifications:
- Bachelor’s degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or related field with 10+ years of related pharmaceutical experience.
- Extensive hands-on downstream biologics process development experience, including purification process optimization and scale-up for protein-based drug substances.
- Strong knowledge of chromatography, filtration, UF/DF, TFF, polishing steps, viral clearance, process characterization, and scale-down model development.
- Proven experience supporting CMC/regulatory filings (technical reports, process descriptions, tech transfer documents, regulatory agency responses).
Preferred Qualifications:
- Master’s or PhD.
- Experience with mammalian cell culture-derived biologic products.
- Understanding of GMP, QbD, DoE, process characterization, control strategy development, and risk assessment.
- Experience developing/scaling/tech transferring/commercializing complex biological products.
- Experience working with manufacturing, TS/MS, Quality, Regulatory, Supply Chain, Launch Teams, and external CDMOs.
- Strong leadership/interpersonal skills; ability to influence stakeholders and lead cross-functional technical teams.
- Ability to manage multiple priorities, navigate ambiguity, and communicate clearly.
- Animal health industry experience.
Additional Information:
- Location: Indianapolis, IN
Responsibilities:
- Lead downstream process unit operation improvement programs for manufactured biologics, developing and optimizing purification processes using phase-appropriate strategies and QbD principles.
- Design and execute bench- and pilot-scale studies, including scale-down model development, process scale-up, and providing manufacturing support.
- Support risk assessments, control strategy development, stage-gate reviews, and technical decision-making for biologic drug substance programs.
- Author and review technical reports, process development documents, tech transfer packages, and CMC regulatory submissions; support responses to regulatory agencies.
- Partner with R&D, MS&T, Manufacturing, Quality, and external CDMOs to ensure successful tech transfer and adoption of process improvements as a downstream process development SME.
Minimum Qualifications:
- Bachelor’s degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or related field with 10+ years of related pharmaceutical experience.
- Extensive hands-on downstream biologics process development experience, including purification process optimization and scale-up for protein-based drug substances.
- Strong knowledge of chromatography, filtration, UF/DF, TFF, polishing steps, viral clearance, process characterization, and scale-down model development.
- Proven experience supporting CMC/regulatory filings (technical reports, process descriptions, tech transfer documents, regulatory agency responses).
Preferred Qualifications:
- Master’s or PhD.
- Experience with mammalian cell culture-derived biologic products.
- Understanding of GMP, QbD, DoE, process characterization, control strategy development, and risk assessment.
- Experience developing/scaling/tech transferring/commercializing complex biological products.
- Experience working with manufacturing, TS/MS, Quality, Regulatory, Supply Chain, Launch Teams, and external CDMOs.
- Strong leadership/interpersonal skills; ability to influence stakeholders and lead cross-functional technical teams.
- Ability to manage multiple priorities, navigate ambiguity, and communicate clearly.
- Animal health industry experience.
Additional Information:
- Location: Indianapolis, IN