Principal Research Scientist - Product development

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Senior Research Scientist for Parenteral Drug Products in Small Molecule

Elanco Headquarter Indianapolis, US

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 of this role include development activities of the entire drug product development life cycle such as development of prototype formulations, study material supply (GMP and non-GMP), coordination of development activities with internal and external partners, and the management of internal lab unit(s).

The person in this role will apply scientific/technical expertise to address complex formulation development tasks within product development and to author documents supporting submissions in coordination with regulatory affairs personnel.

This position is expected to incorporate Quality by Design (QbD) principles throughout the development process.

The person in this role supports identification and selection of Contract Research/Development/Manufacturing Organizations (CRO/CDO/CMO) and provides technical oversight of external development work.

Functions, Duties, Tasks:


* Plan, execute and coordinate daily and weekly work schedule in the formulation lab, with a focus on sterile product development, including sustained release and long-acting parenteral small molecule and peptide dosage forms.


* Design, review and make recommended changes to scientific protocols and procedures, particularly for aseptic processing and sterile manufacturing.


* Perform data analysis.


* Present results at team, project or functional meetings.


* Perform troubleshooting activities related to parenteral formulation stability, sterility, and manufacturing processes.


* Write reports and may write external publications.

Prepare SOPs/working procedures.

Support preparation of registration documents.


* Contribute to evaluation of new scientific technologies and procedures, especially in parenteral drug delivery.


* Collaborate with o...