Research Associate Downstream Process Development Jobs in Indiana

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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

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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