Stability Coordinator, Biologics

Elanco; Kansas; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

Annual bonus offering

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Stability Coordinator in Elwood, KS to manage global stability programs supporting regulatory filings and shelf-life extensions. The role collaborates with QA, Regulatory Affairs, Development, and Manufacturing to ensure robust stability data and timely regulatory submissions.

The candidate will lead investigations into OOT/OOS events, develop study plans, SOPs, and technical reports while mentoring staff and driving process improvements within a 24/7 manufacturing

Qualifications

• Bachelor’s degree in biological or pharmaceutical science or 5 years’ experience.

Responsibilities

• Direct and manage global stability programs to support product registrations and shelf-life extensions.
• Coordinate cross-functional work with QA, Regulatory Affairs, Development, Manufacturing, and Labs.
• Lead investigations of out-of-trend (OOT) and out-of-specification (OOS) events and implement CAPAs.
• Develop stability studies, write SOPs, and ensure data integrity and regulatory compliance.
• Mentor staff on stability requirements and participate in data migration initiatives.

Skills

Stability coordination

Diversity collaboration

Education

Bachelor’s degree in biological or pharmaceutical science

Job description

## Stability Coordinator, BiologicsApply: 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 <10%* 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 underrecognized 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 may be the right candidate for this role or other roles! **Elanco Benefits and Perks:**We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:* Multiple relocation packages* 8-week parental leave* 9 Employee Resource Groups* Annual bonus offering* Flexible work arrangements* Up to 6% 401K matching