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

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 Details Travel: 5-10% Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification.

At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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 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 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.