Senior Scientist -Technical Services, Downstream Process Improvement

Indiana Ag Connection; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

Elanco, a global leader in animal health, seeks a Senior Scientist in Indianapolis to lead downstream process development and purification optimization for biologics from bench-scale to commercial manufacturing.

You will drive chromatography and filtration improvements, support tech transfer and regulatory submissions, and collaborate across R&D, Manufacturing, and Quality to ensure robust processes and reduced costs.

Qualifications

• Bachelor-level degree with 10+ years in pharmaceutical science or related field.
• Hands-on experience in downstream biologics process development and scale-up.
• Experience with chromatography, filtration, UF/DF, and viral clearance.

Responsibilities

• Lead downstream process unit operation improvement programs for manufactured biologics.
• Design bench- and pilot-scale studies, including scale-down models.
• Support risk assessments, control strategy development, and stage-gate reviews.
• Author and review technical reports, tech transfer packages, and regulatory submissions.
• Collaborate with R&D, MS&T, Manufacturing, Quality, and external CDMOs.

Skills

Downstream process development

Chromatography

Filtration

Scale-up & tech transfer

QbD principles

CMC/regulatory submissions

Cross-functional collaboration

Leadership

GMP knowledge

Biologics experience

Education

Bachelor's degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering

Master's or PhD (preferred)

Job description

# Senior Scientist -Technical Services, Downstream Process ImprovementBack to search resultsApply to this positionFollow CompanyMore Jobs from ElancoSend to Friend**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 / 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 Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.To apply please click on APPLY TO THIS POSITION