Consultant, Product Development

About the Role

The Biopharma Technical Development team located in Indianapolis, IN is seeking a Scientist responsible for providing 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.

Key Responsibilities

• Downstream Process Development & Experimentation:
• Design and conduct downstream process development experiments supporting early- and late-stage biological programs (monoclonal antibodies, therapeutic proteins, and other modalities).
• Apply principles of Quality by Design (QbD) to process development, process characterization, and risk mitigation.
• Serve as a key downstream technical resource for Biopharma Technical Development, TS/MS, and commercial manufacturing teams.
• Scale-Up, Tech Transfer & Implementation:
• Support scale-up and technology transfer activities to both internal manufacturing sites and external CDMO/CRO partners.
• Support process implementation and clinical material production runs across bench, pilot, and manufacturing scales.
• Data Analysis & Technical Documentation:
• Review, interpret, and present process and analytical data clearly to key project stakeholders and leadership.
• Author, review, and edit critical source documents, including risk assessments, development reports, batch records, and regulatory support documentation.

Requirements & Tech Stack

• Education: Bachelor’s (B.S.) or Master’s (M.S.) degree in Chemistry, Biology, Microbiology, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Experience:
• M.S. with 0–2 years of relevant, hands-on laboratory experience (industry or academic).
• B.S. with 5+ years of relevant, hands-on laboratory experience (industry or academic).
• Direct experience in downstream biologics process development (preferably for mammalian cell culture-based products) or in protein purification.
• Technical Skills: Demonstrated ability to apply scientific principles to solve process development challenges, coupled with foundational knowledge of experimental design, data analysis, and process scale-up principles.

Additional Preferences

• Direct hands-on experience developing downstream unit operations, including chromatography, UF/DF (tangential flow filtration), and standard filtration unit operations.
• Demonstrated track record in the development, process characterization, and scale-up of a biological modality to manufacturing.
• Solid understanding of upstream cell culture operations and analytical methods used to characterize biologics.
• Experience working within a cGMP regulated biopharmaceutical environment.
• Proven ability to manage multiple priorities, navigate ambiguity, and work effectively both independently and within interdisciplinary teams.
• Strong scientific/technical writing and presentation capabilities.
• Prior experience in the Animal Health industry (preferred, but not essential).

Work Environment & Travel

• Work Location: Global Elanco Headquarters, Indianapolis, IN.
• Work Arrangement: Hybrid (mix of on-site laboratory/office presence and remote work).
• Travel: Approximately 10% domestic and/or international business travel.