QC Stability Manager

FRS Recruitment; Limerick; Vor Ort; EUR 68.000 - 83.000; Vollzeit

Benefits dieser Stelle

Healthcare

Pension

Stock options

Dental cover

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

5+ years experience

Stability programmes

Data analysis

GMP

Regulatory requirements

Statistical tools

Documentation

Tools

JMP

Jobbeschreibung

I am delighted to be partnering with a company within the Biopharmaceutical sector to recruit an experienced Stability Manager.

This is an excellent opportunity for an experienced Stability, QC or Analytical professional to take ownership of a complex and evolving GMP stability programme, supporting both clinical and commercial biological products.

The Opportunity

As Stability Manager, you will be responsible for managing all aspects of the stability programme, including study design, protocol development, data monitoring, statistical trending, reporting and shelf-life assessment.

You will work closely with cross functional teams and play a key role in ensuring stability activities meet the required scientific, technical and regulatory standards.

Key Responsibilities

• Design, coordinate and execute stability studies for clinical and commercial gene therapy products
• Develop, review and maintain stability protocols, reports, SOPs and associated GMP documentation
• Analyse, trend and interpret stability data using statistical tools such as JMP
• Apply analytical expertise to support scientifically robust stability assessments
• Manage stability-related Deviations, Change Controls, CAPAs and investigations
• Drive continuous improvement across stability processes and systems
• Ensure the GMP stability programme remains aligned with FDA, EU, ICH and other applicable regulatory requirements
• Support members of the stability team
• Work cross-functionally with QC, QA, Analytical Development, Manufacturing, Regulatory and Product Development teams
• Ensure ongoing compliance with GMP, Data Integrity and Good Documentation Practice

The Ideal Candidate

I am keen to speak with professionals who have:

• 5+ years' experience within the Pharma or Biotech industry
• Strong experience in stability programmes, ideally within biologics or advanced therapies
• A strong 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 analysisStrong experience working within a GMP regulated environment
• Excellent technical writing, documentation and stakeholder management skills
• Experience supporting IND, NDA or BLA submissions would be highly advantageous.

Salary: €75,000+ plus bonus and a strong benefits package including healthcare, dental cover, pension and stock options.

Excellent opportunity for an experienced Stability professional to take ownership of a key function within a growing advanced therapies organisation.

This is not a people manager role.

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