Principal Research Scientist - Product development

At Elanco (NYSE: ELAN), we are a global leader in animal health dedicated to innovation and delivering products and services that prevent and treat disease in farm animals and pets. Our vision, Food and Companionship Enriching Life, and our purpose—Go Beyond for Animals, Customers, Society and Our People—drive us forward. We foster a diverse and inclusive work environment where innovation, creativity, and collaboration thrive.

About the role

This position is responsible for formulation development and related activities associated with the development of animal health products, specifically focusing on parenteral dosage forms within Small Molecule Technical Development. Responsibilities include the entire drug product development life cycle: development of prototype formulations, study material supply (GMP and non-GMP), coordination with internal and external partners, and management of internal lab unit(s). The role applies scientific/technical expertise to address complex formulation development tasks and authors documents supporting regulatory submissions. Quality by Design (QbD) principles are incorporated throughout the development process. The role also supports identification and selection of Contract Research/Development/Manufacturing Organizations (CRO/CDMO) and provides technical oversight of external development work.

Responsibilities

• Plan, execute, and coordinate daily and weekly work schedules in the formulation lab, focusing on sterile product development, including sustained release and long-acting parenteral small molecule and peptide dosage forms.
• Design, review, and recommend changes to scientific protocols and procedures, particularly for aseptic processing and sterile manufacturing.
• Perform data analysis and present results at team, project, or functional meetings.
• Troubleshoot issues related to parenteral formulation stability, sterility, and manufacturing processes.
• Write reports, external publications, SOPs, and working procedures; support preparation of registration documents.
• Contribute to evaluation of new scientific technologies and procedures, especially in parenteral drug delivery.
• Collaborate with other associates and scientists to facilitate knowledge exchange; train and coach peers; may supervise local team members.
• Maintain laboratory infrastructure, ensuring an organized, clean, and safe working environment while adhering to sterile environment protocols.
• Schedule and perform maintenance of instruments/equipment; evaluate new laboratory equipment.
• Oversee the work of external partners, evaluate results, and define next steps.
• Work according to external and internal guidelines (e.g., SOPs, GxP, HSE, and AW), with a strong emphasis on cGMP for sterile products.

Requirements

• PhD in pharmaceutical science with a minimum of 5 years of proven experience in the pharmaceutical industry.
• Experience in formulation development of parenteral dosage forms and process scale-up with a demonstrated record of success.
• Proven track record of projects involving technologies such as lyophilization, sterile filtration, aseptic filling, and sustained-release injectables.
• Expertise in long-acting and depot dosage forms is ideal.
• Strong working knowledge of GMP and industry/global regulatory guidelines (e.g., VICH, ICH), specifically pertaining to sterile product manufacturing and quality control.
• Ability to work effectively and flexibly within and across Elanco R&D teams, manufacturing, and external collaborators.
• Innovative mindset.

Language requirement: English.

Travel requirement: approximately 5-10%.

Benefits

• Multiple relocation packages.
• Two weeklong shutdowns (mid-summer and year-end) in the U.S. (in addition to PTO).
• 8-week parental leave.
• 9 Employee Resource Groups.
• Annual bonus offering.
• Flexible work arrangements.
• Up to 6% 401K matching.