What are the responsibilities and job description for the Senior Scientist -Technical Services, Downstream Process Improvement position at Elanco?
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Your Role: Senior Scientist, Downstream Process Development / Optimization
Elanco is seeking a Senior Scientist, Downstream Process Development to lead purification process development and optimization for biologic drug substances, focusing on enhancing process robustness and reducing costs for molecules from bench-scale through commercial manufacturing. This role requires hands-on experience with purification processes like chromatography and filtration, partnering cross-functionally to ensure successful tech transfer, implementation, and regulatory support in a fast-paced environment.
Your 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.
What You Need to Succeed (minimum qualifications):
- Education: 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.
What Will Give You a Competitive Edge
- Master's or PhD highly preferred
- Experience with mammalian cell culture-derived biologic products
- Understanding of GMP, Quality by Design, DoE principles, 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.
- Ability to manage multiple priorities, navigate ambiguity, and communicate complex technical information through clear writing and presentations.
- Animal health industry experience.
Additional Information:
- Travel:<10%
- Location:Indianapolis, IN
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