Stability Coordinator, Biologics

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

• 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.

Additional information

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

• #LI-HL
• #LI-Onsite

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.