Stability Coordinator, Biologics

### Job Details####

Job Title:

Stability Coordinator, Biologics ####

Location:

Elwood, KS, Midwest United States,USA #### Company:

Elanco #### Industry Sector:

Agribusiness ####

Industry Type:

Input Retail, Cooperative and Related Crop Services #### Career Type: #### Job Type:Full Time #### Minimum Years Experience

Required:

N/A #### Salary: ### Get Job Alerts
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** 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

* Location:

Elwood, KS
* The Elwood manufacturing facility is a 24/7/365 operation. This role primarily supports standard business hours but may occasionally require off-hour support to meet operational or compliance needs.
** Don't meet every single requirement?
** Studies have shown under recognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You…