Stability Coordinator, Biologics

About the Role

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.

Key Responsibilities

• 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.

Requirements & Tech Stack

• Biological or pharmaceutical science (or closely related field) Bachelor’s Degree OR 5 years’ experience.
• Good verbal, written, and interpersonal communication skills.
• Computer literacy skills.
• Technical writing skills.
• Industry experience in stability coordination in biologics.
• Ability to work with a diverse group of colleagues.

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.