Elanco
Senior Research Scientist, Biologics Drug Product Formulation & Sterile Process Development
Indianapolis, IN · Senior
Sponsorship not specifiedDetected 15 days ago
AlgorithmsMachine LearningCustomer SupportGMPResearchLeadershipCommunication
About the role
- At Elanco (NYSE: ELAN) - it all starts with animals!
- We believe that diversity is the driving force behind innovation, creativity, and overall business success.
- Making animals' lives better makes life better - join our team today!
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.
- 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.
Requirements
- Qualified candidates must be legally authorized to be employed in the United States.
- 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
- 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.
Skills
- These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions.
Compensation
- Annual bonus offering
Benefits
- 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
Company info
- At Elanco we are dedicated to building a diverse and inclusive work environment.
This listing is sourced directly from Elanco's careers page and normalized into a canonical job model.