Position DescriptionAs the Formulations Senior Research Scientist, you will develop robust formulations and manufacturing processes needed to advance Elanco's biopharmaceutical portfolio for global markets. In this role, you will provide day-to-day technical support for formulation activities covering Elanco's biologics portfolio, including monoclonal antibodies, recombinant proteins, and vaccines. A key focus is the modernization of formulation workflows, leveraging automation and high-throughput screening to improve lab efficiency and utilizing AI/ML tools to predict stability and streamline development timelines. This role involves establishing the formulation strategy, identifying future capabilities and leading the technical transfer of robust processes to manufacturing sites. It requires a deep understanding of drug product stability, process scale-up, and sterile manufacturing. Beyond the lab responsibilities, this role also includes authoring and executing batch records, experimental protocols, and technical reports, as well as the preparation and review of the CMC (Chemistry, Manufacturing, and Controls) portion of global regulatory submissions. This position is based in Indianapolis and requires routine interaction with scientists across discovery, development, manufacturing and quality. The ability to independently conceptualize and execute experiments, coupled with a "can do" attitude, is essential. This is a high visibility position serving as the lead scientist on various product teams in R&D, requiring excellent communication skills and the ability to navigate complex US and EU regulatory landscapes.
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 significantly reduce development cycles.
- Leverage knowledge/experience 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 the delivery of an 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.
- Effectively apply QbD principles throughout the development lifecycle to ensure manufacturing concerns are addressed at phase-appropriate points.
- Write, review or approve high quality technical reports, batch records and global regulatory submissions.
- Provide technical oversight for Contract Research/Manufacturing Organizations (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/chemical/bio engineering or related field with a minimum of 5 years relevant experience or MS +10 years relevant experience in the pharmaceutical/biotech industry, specifically in biologics formulation and sterile manufacturing.
- Qualified candidates must be legally authorized to be employed in the United States.
Additional Skills/Preferences- Prior relevant process/product commercialization experience with a focus on process robustness/reliability and effective control strategy development.
- Experience working within a cGMP-regulated environment
- Familiarity with using 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 with a 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.
Additional DetailsTravel: 5-10%
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
