Senior Scientist, Downstream Process Development

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.

Making animals’ lives better makes life better – join our team today!

Your Role: Senior Scientist, Downstream Process Development

Elanco is seeking a Senior Scientist, Downstream Process Development to lead purification process development for biologic drug substances, with a focus on monoclonal antibodies, therapeutic proteins, and mammalian cell culture-derived biologics.

This role will support programs from bench and pilot scale through process scale-up, technology transfer, process characterization, GMP manufacturing implementation, clinical material production, and CMC/regulatory filing support.

The ideal candidate will have hands-on experience developing and optimizing downstream purification processes, including chromatography and filtration-based unit operations such as Protein A or affinity chromatography, ion exchange chromatography, polishing steps, viral clearance or viral inactivation, depth filtration, UF/DF, TFF, and scale-down model development.

You will partner closely with R&D, TS/MS, Manufacturing, Quality, Supply Chain, Regulatory, and external CDMOs to ensure successful process transfer, implementation, and commercialization.

This role requires strong technical judgment, clear communication, and the ability to lead cross-functional work in a fast-paced biologics development environment.

 

Your Responsibilities



* Lead downstream process development for early- and late-stage biologic programs, including monoclonal antibodies, therapeutic proteins, and other biologic modalities.


* Develop and optimize purification processes using phase-appropriate strategies, QbD principles, and process characterization approaches.


* Design and execute bench- and pilot-scale studies, including scale-down model development, process scale-up, and 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 source documents for regulatory submissions.


* Support responses to CMC questions from regulatory agencies.


* Partner with R&D,...