Biologics Stability Lead – Global Programs

Kansas Ag Connection; Kansas; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee resource groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco in Elwood, KS seeks a Stability Coordinator to manage global stability programs across product portfolios, ensuring regulatory compliance and timely data submission. You will work with Quality Assurance, Regulatory Affairs, Development, Manufacturing, and Laboratory Operations to drive studies, data analysis, and continuous process improvement.

The role requires a Bachelor's in biological/pharmaceutical sciences or equivalent experience, strong communication skills, and ability to lead

Qualifications

• Bachelor's degree in biological or pharmaceutical science or 5 years of related experience.
• Excellent verbal, written, and interpersonal communication; strong computer literacy and technical writing skills.
• Industry experience in stability coordination in biologics and ability to work with a diverse group of colleagues.

Responsibilities

• Direct global stability programs to support product commercialization, lifecycle management, shelf-life extensions, and regulatory commitments.
• Develop and execute stability protocols, reports, and study plans per regulatory requirements and internal quality standards.
• Analyze stability data to identify trends and support product quality decisions.
• Lead investigations related to OOT, OOS, and stability failure events; implement CAPAs as required.
• Coordinate stability studies and manage testing schedules to meet timelines and regulatory commitments.
• Author, review, and revise SOPs, protocols, technical reports, and quality system documentation.
• Train and mentor personnel on stability program requirements and regulatory expectations.
• Work with cross-functional teams to ensure data integrity and regulatory compliance.

Skills

Stability coordination

Diversity collaboration

Education

Bachelor's degree in biological/pharmaceutical sciences

Job description

Elanco in Elwood, KS seeks a Stability Coordinator to manage global stability programs across product portfolios, ensuring regulatory compliance and timely data submission. You will work with Quality Assurance, Regulatory Affairs, Development, Manufacturing, and Laboratory Operations to drive studies, data analysis, and continuous process improvement.

The role requires a Bachelor's in biological/pharmaceutical sciences or equivalent experience, strong communication skills, and ability to lead