Stability Coordinator, Biologics

Elanco; Elwood (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work

401K matching

Job summary

Elanco is seeking a stability program leader to manage global stability activities across product portfolios in a 24/7 Elwood, KS facility. The role collaborates with QA, Regulatory, Development, Manufacturing, and Lab Operations to ensure timely regulatory data submission.

Ideal candidates have a biology/pharma background, strong communication, and experience in stability coordination. Occasional travel is expected; relocation support may be available.

Qualifications

• Bachelor’s Degree in biological or pharmaceutical science, or closely related field, or 5 years’ experience.
• Good verbal, written, and interpersonal communication skills; strong technical writing.

Responsibilities

• Direct global stability programs to support product commercialization and lifecycle management.
• Develop and execute stability protocols, reports, and study plans per regulatory standards.
• Analyze stability data to identify trends and support quality decisions.
• Lead investigations of out-of-trend (OOT) and out-of-specification (OOS) events with CAPAs.
• Coordinate stability studies and manage testing schedules to timelines.
• Author, review, and revise SOPs, protocols, reports, and QA documentation.
• Train and mentor personnel on stability requirements and regulatory expectations.
• Work with cross-functional teams to ensure data integrity and compliance.
• Own stability equipment validations and lifecycle management.

Skills

Stability coordination in biologics

Cross-functional leadership

Education

Bachelor’s Degree in biological or pharmaceutical science

Job description

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

• Multiple relocation packages 8-week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401K matching #LI-HL #LI-Onsite

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet.

Learn more at www.elanco.com.