Lead Stability Scientist – R&D & Regulatory Strategy

HERO Recruitment Ltd.; Connacht; On-site; EUR 65,000 - 90,000; Full time

Job summary

HERO Recruitment Ltd. is seeking a Stability Specialist – SME in Co. Mayo, Ireland. The role supports R&D stability activities, develops strategies for expiration dating, and ensures regulatory-compliant stability programs across global teams and CROs.

Key duties include study design, data trend analyses, and authoring regulatory stability sections, with oversight of multiple complex projects and budget considerations.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Master’s or PhD in a relevant field preferred.
• Strong attention to detail and decision-making ability.
• Ability to organize complex information and solve problems.
• Experience with sophisticated databases and data analysis.
• Proficiency with word processing, spreadsheets and reporting tools.
• Knowledge of ICH, GMP, and cGxP regulations.

Responsibilities

• Represent R&D–Stability on project teams to achieve goals.
• Design and implement stability strategies for new products.
• Develop GMP stability studies to establish dating and labeling.
• Prepare technical justifications for expiration dating.
• Perform stability assessments for products and changes.
• Oversee stability study administration via LIMS.
• Coordinate with CROs and global teams; budget forecasting.
• Author stability sections for regulatory submissions.

Skills

Attention to detail

Decision making

Logical, methodical approach

Verbal and technical writing

Team collaboration across time zones

Education

Bachelor’s degree in a scientific discipline

Master’s or PhD in relevant discipline

Tools

LIMS

Databases

Reporting tools

Job description

HERO Recruitment Ltd. is seeking a Stability Specialist – SME in Co. Mayo, Ireland. The role supports R&D stability activities, develops strategies for expiration dating, and ensures regulatory-compliant stability programs across global teams and CROs.

Key duties include study design, data trend analyses, and authoring regulatory stability sections, with oversight of multiple complex projects and budget considerations.