Stability Coordinator, Biologics

## Stability Coordinator, Biologics Apply:
Elwood, KS:
Full time:
Posted Today: R0027500
** 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 with a diverse group of colleagues.
** What Will Give You a Competitive Edge (preferred qualifications):
*** Stability Program Management
* Regulatory Compliance
* Data Trending and Analysis
* OOT/OOS Investigations
* Cross-Functional Leadership
* Quality Systems
* Risk Assessment
* Training and Mentoring
* Process Improvement
* Project Coordination
** Additional Information:
*** Travel:
Occasional