Principal Scientist, Downstream Biologics

Elanco•Indianapolis, IN

6d•Hybrid

About The Position

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 / Principal Scientist, Downstream Process Development The Biopharma Technical Development team located in Indianapolis, IN is seeking a Senior / Principal Research Scientist to provide scientific and technical expertise for the development and launch of new biological drug substances in an innovative and fast-paced organization. This role is focused on downstream process development with an emphasis on monoclonal antibodies, therapeutic proteins, and other biological modalities. You will be responsible for leading downstream process development activities at bench and pilot scales, supporting scale-up, technical transfers, process implementation, and clinical material production at both internal and external manufacturing sites. In addition to technical excellence, this position requires strong organizational management, communication skills, and cross-functional collaboration across departments and geographies. As a subject matter expert in downstream process development, you will have the potential to lead both projects and people.

Requirements

Education: MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, or chemical engineering. Equivalent experience may be considered.
Experience: Minimum 7 years (PhD) or 12+ years (MSc) in downstream biologics process development (preferably mammalian cell culture–based products) or equivalent late-stage/commercialization experience in biological/pharmaceutical products.
Strong understanding of protein purification development process and done this hands on (therapeutics, protein modality, or gene therapy) and worked on tech transfer process and transferred to a manufacturing facility while also gone through a regulatory filing procedure.

Nice To Haves

Strong understanding of GMP and Quality by Design (QbD) principles ; experience with AI/ML applications a plus.
Demonstrated success in developing or commercializing biologics, pharmaceuticals, or vaccines .
Strong interpersonal and leadership skills, with the ability to influence stakeholders and lead interdisciplinary teams .
Proven ability to manage multiple priorities, navigate ambiguity, and deliver clear scientific/technical writing and presentations .
Experience in animal health (advantageous but not required).

Responsibilities

Provide scientific expertise in downstream process development for early- and late-stage biologic programs (mAbs, therapeutic proteins, and other modalities) using phase-appropriate development strategies.
Apply Quality by Design (QbD) principles to process development and process characterization.
Lead and contribute to risk assessments supporting product development stage-gate reviews and robust manufacturing control strategies.
Develop representative scale-down models from commercial-scale operations and apply prior knowledge to guide development studies.
Author and review source documents for regulatory submissions; respond to CMC questions from regulatory agencies.
Partner with R&D, Technical Services/Manufacturing Sciences (TS/MS), supply chain, Quality, Manufacturing, Launch Leaders, external CDMOs, and other stakeholders to ensure successful tech transfers and commercialization.
Serve as a technical resource to Biopharma Technical Development, TS/MS, CMOs, and manufacturing operations.