Senior Research Scientist, Biologics Drug Product Formulation & Sterile Process Development

Position Description As the Formulations Senior Research Scientist, you will develop robust formulations and manufacturing processes needed to advance Elanco’s biopharmaceutical portfolio for global markets. You will provide day‑to‑day technical support for formulation activities covering Elanco’s biologics portfolio, including monoclonal antibodies, recombinant proteins, and vaccines. The role focuses on modernizing formulation workflows, leveraging automation, high‑throughput screening, and AI/ML tools to predict stability and streamline development timelines. It includes establishing formulation strategy, identifying future capabilities, and leading the technical transfer of robust processes to manufacturing sites. The position is based in Indianapolis and requires routine interaction with scientists across discovery, development, manufacturing, and quality. Key Responsibilities Lead the design and development of biologics formulations, utilizing high‑throughput screening (HTS) platforms to rapidly evaluate excipient compatibility and physical‑chemical stability. Implement and oversee automated equipment/workflows to improve efficiency. Apply AI/ML modeling and predictive analytics to streamline formulation selection, optimize stability profiles, and reduce development cycles. Leverage knowledge to scale‑up and develop a robust sterile manufacturing process. Lead and execute the technical transfer of drug product formulations and manufacturing processes from R&D to clinical and internal commercial manufacturing sites. Lead the Manufacturability Review process, ensuring effective process/product control strategy. Play a leadership role in material delivery activities for pivotal CT and registration stability supply. Lead troubleshooting activities related to parenteral formulation stability, sterility, and manufacturing deviations. Apply QbD principles throughout the development lifecycle to address manufacturing concerns at phase‑appropriate points. Write, review or approve high‑quality technical reports, batch records and global regulatory submissions. Provide technical oversight for CRO/CMO and external consultants. Work effectively across all R&D teams, manufacturing and with external collaborators. Basic Qualifications Ph.D. in pharmaceutical sciences, biochemistry, chemistry, bioengineering or related field with a minimum of 5 years of relevant experience, or M.S. with 10 years of relevant experience in the pharmaceutical/biotech industry, specifically in biologics formulation and sterile manufacturing. Qualified candidate must be legally authorized to be employed in the United States. Additional Skills & Preferences Process/product commercialization experience focused on process robustness/reliability and effective control strategy development. Experience within a cGMP‑regulated environment. Familiarity with machine learning algorithms or predictive modeling software to accelerate drug product development. Hands‑on experience with automated platforms (e.g., liquid handlers, robotic samplers) and plate‑based high‑throughput tools. Experience in multiple technology platforms (e.g., lyophilized products, lipid nanoparticles, adjuvanted formulations). Strong strategic thinking skills and track record of using innovative technologies to solve complex formulation challenges. Strong interpersonal skills and proven ability to lead project teams and influence cross‑functional partners in R&D, Manufacturing, and Quality. Travel 5–10% Benefits and Perks Comprehensive benefits package focusing on financial, physical, and mental well‑being. Multiple relocation packages. Two weeklong shutdowns (mid‑summer and year‑end) in the US, in addition to PTO. 8‑week parental leave. Annual bonus offering. Flexible work arrangements. Up to 6% 401(k) matching. EEO Statement 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. #J-18808-Ljbffr Elanco Tiergesundheit AG