Senior Scientist, Downstream Process Development

About the role

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.

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, 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.

Requirements

• MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or a related scientific discipline.
• 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.

Qualifications

• 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.
• Able to manage multiple priorities, navigate ambiguity, and communicate complex technical information through clear writing and presentations.
• Experience with AI/ML applications in process development is a plus.
• Animal health experience is advantageous but not required.