Stability Programs Lead (FDA‑Regulated, Data‑Driven)

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 44,900 - 74,950; Full time

Benefits offered by this job

Annual performance bonus

Comprehensive health benefits

Tuition reimbursement

Job summary

Hikma Pharmaceuticals is seeking a Stability Administrator in Bedford, Ohio, to coordinate stability programs for oral and sterile injectable products, ensuring compliance with ICH guidelines and FDA regulations.

The ideal candidate will have a Bachelor’s degree in a relevant field and 2–5+ years of experience in the pharmaceutical industry, focusing on stability and data integrity.

The role offers competitive compensation, a comprehensive benefits package, and opportunities for career advancement.

Qualifications

• 2–5+ years of experience in stability, QC, or GMP documentation.
• Experience in FDA-regulated environments required.
• Experience with sterile products preferred.

Responsibilities

• Manage stability programs in accordance with ICH Q1A(R2).
• Coordinate sample pulls and testing timelines.
• Ensure audit readiness for FDA inspections.

Skills

Understanding of ICH stability requirements (Q1A, Q1B)

Experience with stability tracking systems

Knowledge of data integrity and audit readiness principles

Education

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related discipline

Tools

LIMS

Temperature/humidity monitoring systems

Job description

Hikma Pharmaceuticals is seeking a Stability Administrator in Bedford, Ohio, to coordinate stability programs for oral and sterile injectable products, ensuring compliance with ICH guidelines and FDA regulations.

The ideal candidate will have a Bachelor’s degree in a relevant field and 2–5+ years of experience in the pharmaceutical industry, focusing on stability and data integrity.

The role offers competitive compensation, a comprehensive benefits package, and opportunities for career advancement.