Senior Scientist, Biologics Downstream Process Development

Indiana Ag Connection; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

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

You will drive chromatography and filtration improvements, support tech transfer and regulatory submissions, and collaborate across R&D, Manufacturing, and Quality to ensure robust processes and reduced costs.

Qualifications

• Bachelor-level degree with 10+ years in pharmaceutical science or related field.
• Hands-on experience in downstream biologics process development and scale-up.
• Experience with chromatography, filtration, UF/DF, and viral clearance.

Responsibilities

• Lead downstream process unit operation improvement programs for manufactured biologics.
• Design bench- and pilot-scale studies, including scale-down models.
• Support risk assessments, control strategy development, and stage-gate reviews.
• Author and review technical reports, tech transfer packages, and regulatory submissions.
• Collaborate with R&D, MS&T, Manufacturing, Quality, and external CDMOs.

Skills

Downstream process development

Chromatography

Filtration

Scale-up & tech transfer

QbD principles

CMC/regulatory submissions

Cross-functional collaboration

Leadership

GMP knowledge

Biologics experience

Education

Bachelor's degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering

Master's or PhD (preferred)

Job description

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

You will drive chromatography and filtration improvements, support tech transfer and regulatory submissions, and collaborate across R&D, Manufacturing, and Quality to ensure robust processes and reduced costs.