Stability Manager - Biotech/GMP, Stock Options & Bonus

FRS Recruitment; Limerick; On-site; EUR 68,000 - 83,000; Full time

Benefits offered by this job

Healthcare

Pension

Stock options

Dental cover

Job summary

FRS Recruitment partners with a Biopharmaceutical company in Ireland to recruit an experienced Stability Manager. The role is to own the GMP stability programme for clinical and commercial biologics, designing studies, monitoring data and ensuring regulatory compliance.

You will work with cross-functional teams (QC, QA, Analytical Development, Manufacturing, Regulatory and Product Development) to drive improvements in stability processes.

Qualifications

• 5+ years' experience within Pharma or Biotech.
• Strong experience in stability programmes, ideally within biologics or advanced therapies.
• Understanding of degradation pathways, accelerated stability testing and shelf-life determination.
• Experience with analytical methodologies and stability indicating testing.
• Strong knowledge of FDA, EU and ICH regulatory requirements.
• Experience applying statistical tools for stability trending and data analysis.
• Experience working in a GMP regulated environment.
• Excellent technical writing, documentation and stakeholder management skills.
• Experience supporting IND, NDA or BLA submissions would be advantageous.

Responsibilities

• Design, coordinate and execute stability studies for clinical and commercial gene therapy products.
• Develop, review and maintain stability protocols, reports, SOPs and GMP documentation.
• Analyse, trend and interpret stability data using JMP or similar tools.
• Apply analytical expertise to support robust stability assessments.
• Manage stability-related deviations, change controls, CAPAs and investigations.
• Drive continuous improvement across stability processes and systems.
• Ensure the stability programme complies with GMP, FDA, EU, ICH requirements and data integrity.
• Support stability team members and work cross-functionally with QC, QA, Analytical Development, Manufacturing, Regulatory and Product Development teams.

Skills

5+ years experience

Stability programmes

Data analysis

GMP

Regulatory requirements

Statistical tools

Documentation

Tools

JMP

Job description

FRS Recruitment partners with a Biopharmaceutical company in Ireland to recruit an experienced Stability Manager. The role is to own the GMP stability programme for clinical and commercial biologics, designing studies, monitoring data and ensuring regulatory compliance.

You will work with cross-functional teams (QC, QA, Analytical Development, Manufacturing, Regulatory and Product Development) to drive improvements in stability processes.