Senior Scientist Downstream Process Development
Overview
Elanco seeks a Senior Scientist leading downstream process development for biologic drug substances. The role drives purification process development across scales from bench to GMP manufacturing. Candidates will partner with cross-functional teams to ensure successful technology transfer and commercialization.
What You'll Do11
- 1Lead downstream process development for early- and late-stage biologic programs
- 2Develop and optimize purification processes using phase-appropriate strategies and QbD principles
- 3Design and execute bench- and pilot-scale studies including scale-down model development
- 4Support risk assessments and control strategy development for biologic programs
- 5Author technical reports and support CMC submissions for regulatory filings
- 6Partner with R&D and manufacturing teams to ensure successful tech transfer and clinical material production
- 7Serve as subject matter expert for downstream process development internally and externally
- 8Contribute to CMC/regulatory filing activities including technical documentation
- 9Apply knowledge of downstream unit operations such as chromatography and filtration
- 10Manage cross-functional projects navigating ambiguity and multiple priorities
- 11Communicate complex technical concepts through clear writing and presentations
Requirements10
- 1MSc or PhD in chemistry pharmaceutical sciences biotechnology chemical engineering or related discipline
- 2Equivalent experience accepted
- 3PhD with 7+ years or MSc with 12+ years in downstream biologics process development
- 4Hands-on experience optimizing downstream purification processes for biologic drug substances
- 5Experience supporting late-stage development and GMP manufacturing implementation
- 6Proficiency in CMC/regulatory filing activities
- 7Strong understanding of chromatography filtration UF/DF TFF polishing steps viral clearance and scale-down models
- 8Ability to lead cross-functional technical teams
- 9Experience with AI/ML applications in process development
- 10Animal health experience preferred
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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