Biologics Project Lead: GMP Analytics & Study Leadership

Charles River Laboratories, Inc.; Ballina; Remote; EUR 65,000 - 85,000; Full time

Job summary

Charles River Laboratories seeks an experienced Project Leader for the Biologics Division in Ballina, Co. Mayo, Ireland. The role reports to the Analytical Development Manager and drives analytical method development, validation, and project management in a GMP environment.

You will lead designs for studies, coordinate with QA for audits, train staff, and liaise with clients on ongoing projects while ensuring compliance with GMP standards.

Qualifications

• Degree in relevant science discipline (e.g. Chemistry, Biochemistry, Biotechnology, Immunology, Pharmaceutical Sciences, Molecular Biology).
• PhD is preferred but not mandatory.
• Minimum of 3 years relevant GMP-regulated experience (EMEA/FDA) in Pharmaceutical/Medical Device/CRO industry.

Responsibilities

• Research and develop new analytical methodologies to meet client requirements and company objectives.
• Ensure all new methods are validated per ICH guidelines where appropriate.
• Lead study plans and execute studies with GMP-compliant SOPs.
• Coordinate with Quality for audit responses, deviation reports and study reports.
• Lead laboratory investigations and report project progress to management.
• Provide technical training to the scientific team as required.
• Liaise with clients regarding current and new projects.

Skills

Project management

Study design

Assay development

ICH analytical validation

GMP experience

Problem solving

Education

Degree in relevant science discipline

PhD (preferred)

Tools

Statistical software

Job description

Charles River Laboratories seeks an experienced Project Leader for the Biologics Division in Ballina, Co. Mayo, Ireland. The role reports to the Analytical Development Manager and drives analytical method development, validation, and project management in a GMP environment.

You will lead designs for studies, coordinate with QA for audits, train staff, and liaise with clients on ongoing projects while ensuring compliance with GMP standards.