Stability Coordinator, Biologics

Elanco•Elwood, KS

5d•Onsite

About The Position

Manage global stability programs supporting product registrations, shelf-life extensions, and regulatory compliance across multiple product portfolios. Collaborate with Quality Assurance, Regulatory Affairs, Development, Manufacturing, and Laboratory Operations to execute stability studies and submit regulatory data on time. The role primarily supports standard business hours at Elanco’s Elwood, Kansas manufacturing facility, which operates 24/7/365; occasional off-hour support may be needed for operational or compliance needs. Occasional travel is less than 10%.

Requirements

Bachelor’s degree in biological or pharmaceutical science, or a closely related field, or five years of experience.
Good verbal, written, and interpersonal communication skills.
Computer literacy and technical writing skills.
Industry experience in stability coordination in biologics.
Ability to work with a diverse group of colleagues.

Nice To Haves

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.

Responsibilities

Direct global stability programs supporting product commercialization, lifecycle management, shelf-life extensions, and ongoing regulatory commitments.
Develop and execute stability protocols, reports, and study plans in line with regulatory requirements and internal quality standards.
Analyze stability data, identify trends, assess product performance, and support product quality decisions.
Lead investigations into out-of-trend (OOT), out-of-specification (OOS), and stability failure events, implementing corrective and preventive actions as required.
Coordinate stability studies and testing schedules to meet established timelines and regulatory commitments.
Contribute to stability data migration initiatives.
Author, review, and revise SOPs, protocols, technical reports, and quality system documentation.
Train and mentor personnel on stability program requirements, procedures, and regulatory expectations.
Work with cross-functional teams to support data integrity, regulatory compliance, and continuous improvement of stability processes.
Own stability equipment validations and lifecycle.