Senior Scientist -Technical Services, Downstream Process Improvement

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

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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.

• 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.

• 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.

• Master's or PhD highly preferred
• Experience with mammalian cell culture-derived biologic products
• Understanding of GMP and Quality by Design i.e ...
• and ...

• Travel: