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!

We are 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.

• 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, TS/MS, Manufacturing, Quality, Supply Chain, Regulatory, Launch Teams, and external CDMOs to ensure successful tech transfer, clinical material production, and commercialization.
• Serve as a downstream process development subject matter expert for internal teams, manufacturing sites, and external partners.

• MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or a related scientific discipline. Equivalent experience may be considered.
• PhD with 7+ years or MSc with 12+ years of experience in downstream biologics process development, preferably with mammalian cell culture‑derived biologic products.
• Hands‑on experience developing and optimizing downstream purification processes for biologic drug substances, including monoclonal antibodies, therapeutic proteins, or other protein‑based biologic modalities.
• Experience supporting late‑stage development, process scale‑up, technology transfer, and implementation into GMP manufacturing.
• Experience contributing to CMC/regulatory filing activities, including technical reports, source documents, process descriptions, tech transfer documents, or responses to regulatory agency questions.
• Strong understanding of downstream unit operations such as chromatography, filtration, UF/DF, TFF, polishing steps, viral clearance or viral inactivation, process characterization, and scale‑down model development.

• Strong understanding of GMP, Quality by Design, 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…