Your Role: Senior Scientist, Downstream Process Development / Optimization Elanco is seeking a Senior Scientist, Downstream Process Development to lead purification process development and optimization for biologic drug substances, focusing on enhancing process robustness and reducing costs for molecules from bench-scale through commercial manufacturing. This role requires hands-on experience with purification processes like chromatography and filtration, partnering cross-functionally to ensure successful tech transfer, implementation, and regulatory support in a fast-paced environment. Your Responsibilities • Process Improvement & Development: Lead downstream process unit operation improvement programs for manufactured biologics, developing and optimizing purification processes using phase-appropriate strategies and QbD principles. • Experimental Design & Scale-Up: Design and execute bench- and pilot-scale studies, including scale-down model development, process scale-up, and providing manufacturing support. • Technical Oversight & Strategy: Support risk assessments, control strategy development, stage-gate reviews, and technical decision-making for biologic drug substance programs. • Documentation & Regulatory Compliance: Author and review technical reports, process development documents, tech transfer packages, and CMC regulatory submissions, while supporting responses to regulatory agencies. • Cross-Functional Collaboration & SME: Partner with R&D, MS&T, Manufacturing, Quality, and external CDMOs to ensure successful tech transfer and adoption of process improvements, serving as a downstream process development subject matter expert. What You Need to Succeed (minimum qualifications): • Education: Bachelor's degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or a related scientific discipline with 10+ years of related pharmaceutical experience. • Extensive hands-on experience in downstream biologics process development, including the optimization and scale-up of purification processes for various protein-based drug substances. • Strong understanding of key downstream unit operations such as chromatography, filtration, UF/DF, TFF, polishing steps, viral clearance, process characterization, and scale-down model development. • Proven experience contributing to CMC/regulatory filing activities, including technical reports, process descriptions, tech transfer documents, and responses to regulatory agency questions. What Will Give You a Competitive Edge • Master's or PhD highly preferred • Experience with mammalian cell culture-derived biologic products • Understanding of GMP, Quality by Design, DoE principles, process characterization, control strategy development, and risk assessment principles. • Demonstrated success developing, scaling, transferring, or commercializing biologics, pharmaceuticals, vaccines, or other complex biological products. • Experience working with internal manufacturing teams, TS/MS, Quality, Regulatory, Supply Chain, Launch Teams, and external CDMOs. • Strong interpersonal and leadership skills, with the ability to influence stakeholders and lead cross-functional technical teams. • Ability to manage multiple priorities, navigate ambiguity, and communicate complex technical information through clear writing and presentations. • Animal health industry experience. Additional Information: • Travel: • Location: Indianapolis, IN