Senior Scientist -Technical Services, Downstream Process Improvement

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

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: Senior Scientist, Downstream Process Development / OptimizationElanco 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:

• 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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