Stability Manager – Biologics & GMP

FRS Recruitment; Limerick; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Healthcare

Dental cover

Pension

Stock options

Job summary

FRS Recruitment is partnering with a Biopharmaceutical company to recruit an experienced Stability Manager in Ireland. The role leads the GMP stability programme for clinical and commercial biologics, coordinating study design, data monitoring and shelf-life assessments.

The ideal candidate has 5+ years in stability, strong regulatory knowledge (FDA, EU, ICH) and proven ability to drive data-driven decisions across cross-functional teams, without people management responsibilities.

Qualifications

• 5+ years' experience in pharma/biotech stability.
• Proven track record with stability programmes.
• Strong knowledge of FDA, EU, ICH requirements.
• Excellent technical writing and data interpretation.

Responsibilities

• Design and execute stability studies for clinical and commercial products.
• Develop, review and maintain stability protocols, reports and GMP docs.
• Analyse stability data and perform statistical trending.
• Manage Deviations, Change Controls, CAPAs and investigations.
• Ensure GMP, data integrity and GxP compliance across teams.
• Collaborate with QC, QA, Regulatory, Manufacturing, and Product Development.
• Support IND, NDA or BLA submissions is advantageous.

Skills

Stability programme management

Statistical trending

Documentation & stakeholder management

GMP regulatory understanding

Tools

JMP

Job description

FRS Recruitment is partnering with a Biopharmaceutical company to recruit an experienced Stability Manager in Ireland. The role leads the GMP stability programme for clinical and commercial biologics, coordinating study design, data monitoring and shelf-life assessments.

The ideal candidate has 5+ years in stability, strong regulatory knowledge (FDA, EU, ICH) and proven ability to drive data-driven decisions across cross-functional teams, without people management responsibilities.