Global Stability Coordinator, Biologics & Compliance

Elanco; Kansas; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

Annual bonus offering

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Stability Coordinator in Elwood, KS to manage global stability programs supporting regulatory filings and shelf-life extensions. The role collaborates with QA, Regulatory Affairs, Development, and Manufacturing to ensure robust stability data and timely regulatory submissions.

The candidate will lead investigations into OOT/OOS events, develop study plans, SOPs, and technical reports while mentoring staff and driving process improvements within a 24/7 manufacturing

Qualifications

• Bachelor’s degree in biological or pharmaceutical science or 5 years’ experience.

Responsibilities

• Direct and manage global stability programs to support product registrations and shelf-life extensions.
• Coordinate cross-functional work with QA, Regulatory Affairs, Development, Manufacturing, and Labs.
• Lead investigations of out-of-trend (OOT) and out-of-specification (OOS) events and implement CAPAs.
• Develop stability studies, write SOPs, and ensure data integrity and regulatory compliance.
• Mentor staff on stability requirements and participate in data migration initiatives.

Skills

Stability coordination

Diversity collaboration

Education

Bachelor’s degree in biological or pharmaceutical science

Job description

Elanco is seeking a Stability Coordinator in Elwood, KS to manage global stability programs supporting regulatory filings and shelf-life extensions. The role collaborates with QA, Regulatory Affairs, Development, and Manufacturing to ensure robust stability data and timely regulatory submissions.

The candidate will lead investigations into OOT/OOS events, develop study plans, SOPs, and technical reports while mentoring staff and driving process improvements within a 24/7 manufacturing