Stability & Raw Materials Lead

Vantive; Castlebar; On-site; EUR 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Castlebar seeks a Stability and Raw Materials Lead to oversee the stability program and raw materials management. This role involves ensuring compliance with global regulations and internal standards while managing various teams. Candidates should have a Bachelor’s degree in Chemistry or Pharmaceutical Sciences and experience in pharmaceutical stability and raw material management. The position offers a dynamic work environment and a comprehensive benefits package.

Benefits

Private medical insurance

Company pension scheme

Annual bonus scheme

State-of-the-art equipment and technology

Qualifications

• Experience in pharmaceutical stability programs and raw material management within a GMP environment.
• Strong knowledge of ICH guidelines, cGMP, and regulatory requirements.
• Experience with stability chamber operations and environmental monitoring systems.

Responsibilities

• Develop and maintain stability protocols and schedules.
• Ensure compliance with regulatory standards.
• Manage raw material qualification processes.
• Collaborate with various internal teams to resolve issues.

Skills

Pharmaceutical stability programs

Raw material management

Analytical skills

Problem-solving

Communication

Leadership

Education

Bachelor’s degree in Chemistry or Pharmaceutical Sciences

Tools

LIMS

Job description

The Stability and Raw Materials Lead is responsible for overseeing the finished product stability program and raw material management within Vantive’s manufacturing and quality operations.

This role ensures compliance with global regulatory requirements, internal quality standards, and supports product lifecycle management. The position requires strong technical expertise, leadership skills, and the ability to collaborate cross-functionally to maintain robust systems for stability studies and raw material qualification.

Key Responsibilities

Stability Program Management

• Develop, implement, and maintain stability protocols and schedules for commercial and development products.
• Ensure stability studies comply with ICH guidelines, regulatory filings, and internal SOPs.
• Review and approve stability data, trend analysis, and reports for regulatory submissions and annual product reviews.
• Manage stability chambers and ensure environmental monitoring compliance.

Raw Materials Oversight

• Lead raw material qualification and requalification processes in alignment with GMP and regulatory requirements.
• Collaborate with suppliers and internal teams to resolve material-related issues and ensure supply continuity.
• Maintain raw material specifications and ensure timely updates based on regulatory changes or process improvements.

Compliance & Documentation

• Ensure adherence to cGMP, ICH, and other applicable regulatory standards.
• Support audits and inspections by providing stability and raw material documentation.
• Drive continuous improvement initiatives within stability and raw material programs.

Cross-Functional Collaboration

• Partner with Quality Control, Product Development, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure seamless execution of stability and raw material-related activities.
• Provide technical guidance and training to team members and stakeholders.

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field
• Experience in pharmaceutical stability programs and raw material management within a GMP environment.
• Strong knowledge of ICH guidelines, cGMP, and regulatory requirements.
• Excellent analytical, problem-solving, and organizational skills.
• Effective communication and leadership abilities.

Preferred Skills

• Experience with stability chamber operations and environmental monitoring systems.
• Familiarity with LIMS for raw material and stability data management.
• Project management experience in a regulated environment.

What can Vantive offer to you

• A stable and secure work environment.
• A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme.
• A collaborative and dynamic work environment.
• Access to state-of-the-art equipment and technology.
• Recognition and reward for outstanding performance.