Biologics Project Leader – GMP Analytics & Studies

Charles River Laboratories; Ballina; On-site; EUR 75,000 - 105,000; Full time

Job summary

Charles River Laboratories is seeking an experienced Project Leader for its Biologics Division in Ballina, Ireland. The role involves leading analytical development activities, validating methods per ICH guidelines, and coordinating with Quality and clients to ensure GMP compliance and successful study execution.

The candidate will design studies, manage multiple projects, train staff, and contribute to audit responses and SOP updates while maintaining a focus on regulatory readiness and

Qualifications

• Degree in relevant science discipline; PhD preferred
• GMP/ICH analytical validation experience within pharma/ CRO required
• Experience in study design, assay development, and project management

Responsibilities

• Research and develop analytical methodologies per client requirements and objectives
• Ensure validation per ICH guidelines where appropriate
• Lead study plans and execute studies with GMP compliance
• Coordinate with Quality for audit responses and study reports
• Lead laboratory investigations and report progress to management
• Provide technical training to the scientific team as required
• Liaise daily with clients on current and new projects
• Support regulatory and client audits and equipment qualification
• Generate and update SOPs and risk assessments as needed

Skills

Project management

Scientific research

ICH guidelines

Problem solving

Client liaison

Education

Degree in relevant science

PhD preferred

Tools

HPLC

UPLC

ELISA

SDS-PAGE

CE-SDS

UV/Vis

GC

Job description

Charles River Laboratories is seeking an experienced Project Leader for its Biologics Division in Ballina, Ireland. The role involves leading analytical development activities, validating methods per ICH guidelines, and coordinating with Quality and clients to ensure GMP compliance and successful study execution.

The candidate will design studies, manage multiple projects, train staff, and contribute to audit responses and SOP updates while maintaining a focus on regulatory readiness and