Senior Scientist, Biologic Downstream Process

Elanco; Greenfield (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Travel <10%

Location: Indianapolis

Job summary

Elanco, a global leader in animal health, seeks a Senior Scientist, Downstream Process Development to lead purification process development and optimization for biologics, from bench-scale through commercial manufacturing.

You will design bench- and pilot-scale studies, implement QbD principles, and collaborate across R&D, manufacturing, and quality to ensure successful tech transfer and regulatory readiness.

Qualifications

• 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.

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.

Skills

Downstream process development

Chromatography

Filtration

Scale-up

CMC/regulatory

Cross-functional collaboration

Leadership

GMP

DoE

Tech transfer

Education

Bachelor’s degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or related

Master’s or PhD highly preferred

Job description

Elanco, a global leader in animal health, seeks a Senior Scientist, Downstream Process Development to lead purification process development and optimization for biologics, from bench-scale through commercial manufacturing.

You will design bench- and pilot-scale studies, implement QbD principles, and collaborate across R&D, manufacturing, and quality to ensure successful tech transfer and regulatory readiness.