Biologics Downstream Process Lead

Elanco; Indianapolis (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

Elanco in Indianapolis, IN, is seeking a Senior Scientist, Downstream Process Development to lead purification process development for biologic drug substances from bench-scale through commercial manufacturing, with a focus on robustness and cost reduction.

You will design and optimize unit operations (chromatography, filtration, UF/DF, TFF), execute bench and pilot studies, support tech transfer, risk assessments, and regulatory filings, and collaborate across R&D, MS&T, Manufacturing and

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or a related field with 10+ years of pharmaceutical experience.
• Extensive hands-on experience in downstream biologics process development, including purification processes.
• Strong understanding of chromatography, filtration, UF/DF, TFF and polishing steps.
• Experience contributing to CMC/regulatory filings and tech transfer.

Responsibilities

• Lead downstream process unit operation improvement programs for biologics.
• Design and execute bench- and pilot-scale studies; scale-down model development.
• Provide manufacturing support and phase-appropriate development activities.
• Support risk assessments, control strategy development, stage-gate reviews.
• Author and review technical reports, tech transfer packages, and regulatory responses.
• Collaborate with R&D, MS&T, Manufacturing, Quality, and external CDMOs.

Skills

Downstream process development

Chromatography

Filtration

UF/DF

TFF

Process characterization

Tech transfer

CMC regulatory submissions

QbD principles

Cross-functional collaboration

Education

Bachelor’s degree in chemistry or related field

Job description

Elanco in Indianapolis, IN, is seeking a Senior Scientist, Downstream Process Development to lead purification process development for biologic drug substances from bench-scale through commercial manufacturing, with a focus on robustness and cost reduction.

You will design and optimize unit operations (chromatography, filtration, UF/DF, TFF), execute bench and pilot studies, support tech transfer, risk assessments, and regulatory filings, and collaborate across R&D, MS&T, Manufacturing and