Stability Coordinator, Biologics

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!

Position Description:

Manage global stability programs supporting product registrations, shelf-life extensions, and regulatory compliance requirements across multiple product portfolios.

Collaborate cross-functionally with Quality Assurance, Regulatory Affairs, Development, Manufacturing, and Laboratory Operations to ensure the successful execution of stability studies and timely submission of regulatory data.

 

Functions, Duties, Tasks:

 


* Direct global stability programs to support product commercialization, lifecycle management, shelf-life extensions, and ongoing regulatory commitments.


* Develop and execute stability protocols, reports, and study plans in accordance with regulatory requirements and internal quality standards.


* Analyze stability data to identify trends, assess product performance, and support product quality decisions.


* Lead investigations related to out-of-trend (OOT), out-of-specification (OOS), and stability failure events, implementing corrective and preventive actions as required.


* Coordinate stability studies and manage testing schedules to ensure compliance with established timelines and regulatory commitments.


* Serve as a key contributor to stability data migration initiatives.


* Author, review, and revise Standard Operating Procedures (SOPs), protocols, technical reports, and quality system documentation.


* Train and mentor personnel on stability program requirements, procedures, and regulatory expectations.


* Work closely with cross-functional teams to ensure data integrity, regulatory compliance, and continuous improvement of stability processes.


* Ownership of stability equipment validations and life cycle

 

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s Degree in biological or pharmaceutical science, or closely related field or 5 years’ experience


* Experience: Good verbal, written, and interpersonal communication skills, computer literacy skills, and technical writing skills


* Top 2 Skills: Industry experience in stability coordination in biologics.

Ability to work wi...