Global Biologics Stability Program Lead

Elanco; Elwood (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work

401K matching

Job summary

Elanco is seeking a stability program leader to manage global stability activities across product portfolios in a 24/7 Elwood, KS facility. The role collaborates with QA, Regulatory, Development, Manufacturing, and Lab Operations to ensure timely regulatory data submission.

Ideal candidates have a biology/pharma background, strong communication, and experience in stability coordination. Occasional travel is expected; relocation support may be available.

Qualifications

• Bachelor’s Degree in biological or pharmaceutical science, or closely related field, or 5 years’ experience.
• Good verbal, written, and interpersonal communication skills; strong technical writing.

Responsibilities

• Direct global stability programs to support product commercialization and lifecycle management.
• Develop and execute stability protocols, reports, and study plans per regulatory standards.
• Analyze stability data to identify trends and support quality decisions.
• Lead investigations of out-of-trend (OOT) and out-of-specification (OOS) events with CAPAs.
• Coordinate stability studies and manage testing schedules to timelines.
• Author, review, and revise SOPs, protocols, reports, and QA documentation.
• Train and mentor personnel on stability requirements and regulatory expectations.
• Work with cross-functional teams to ensure data integrity and compliance.
• Own stability equipment validations and lifecycle management.

Skills

Stability coordination in biologics

Cross-functional leadership

Education

Bachelor’s Degree in biological or pharmaceutical science

Job description

Elanco is seeking a stability program leader to manage global stability activities across product portfolios in a 24/7 Elwood, KS facility. The role collaborates with QA, Regulatory, Development, Manufacturing, and Lab Operations to ensure timely regulatory data submission.

Ideal candidates have a biology/pharma background, strong communication, and experience in stability coordination. Occasional travel is expected; relocation support may be available.