Senior Scientist -Technical Services, Downstream Process Improvement

Elanco Tiergesundheit AG; Indianapolis (IN); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Travel <10%

Job summary

Elanco Animal Health Incorporated in Indianapolis, IN, is seeking a Senior Scientist in Downstream Process Development to lead purification process development from bench-scale through commercial manufacturing. The role focuses on robustness, cost reduction, and tech transfer, with hands-on chromatography and filtration expertise.

The candidate should have a strong track record in scale-up, process characterization, and regulatory support, and collaborate across R&D, MS&T, Manufacturing, and

Qualifications

• Bachelor's degree in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or related field.
• 10+ years of downstream biologics process development experience.
• Experience with purification unit operations such as chromatography and filtration.

Responsibilities

• Lead downstream process unit operation improvement programs for biologics.
• Design and execute bench- and pilot-scale studies and scale-up activities.
• Provide manufacturing support and regulatory and risk assessment input.
• Develop and review technical reports, tech transfer packages, and CMC regulatory submissions.
• Collaborate with R&D, MS&T, Manufacturing, Quality and external CDMOs as SME for downstream processes.

Skills

Downstream development

Chromatography

Filtration

Process scale-up

Tech transfer

CMC regulatory

Education

Bachelor's degree in chemistry/biopharma/biotech/chemical engineering

10+ years pharmaceutical downstream experience

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 / 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 and Quality by Design i.e ...
• and ...

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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet.

Learn more at www.elanco.com.