Charles River Laboratories is seeking an Immunoassay Project Leader to join our Biologics Division. In this key onsite role based at our Ballina, Co. Mayo facility, you will lead scientific research and method development projects, ensuring they meet strategic objectives and stringent regulatory standards. You will report to the Analytical Development Manager and play a central role in advancing our mission to improve the quality of people’s lives through excellent science.
What You'll Do
- Research and develop new analytical methodologies to meet client requirements and company strategic goals.
- Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
- Draw up study plans and execute studies in strict accordance with those plans and SOPs, ensuring full GMP regulatory compliance.
- Liaise with the Quality Department for the generation of audit responses, deviation reports, and study reports.
- Execute study plans and complex methods in the laboratory for transfer, validation, or development, leading troubleshooting efforts as required.
- Lead laboratory investigations.
- Report project progress information to Management.
- Provide technical training to the scientific team as needed.
- Serve as the day-to-day liaison with clients regarding current and new projects.
- Participate in regulatory and client audits.
- Ensure all new equipment is qualified and validated per GMP and corporate standards.
- Generate new and update current standard operating procedures.
- Generate risk assessments for various projects as required.
What We're Looking For
- A PhD in a relevant science discipline (e.g., Biochemistry, Biotechnology, or Chemistry).
- Strong proven experience in Scientific Research, preferably within a GMP regulated environment (EMEA/FDA) in the Pharmaceutical, Medical Device, or CRO industry.
- Experience in study design, assay development, optimization, ICH analytical validation, and project management.
- Experience in immunoassay methods (e.g., ELISA, Western Blot) is essential.
- Ability to project manage multiple studies concurrently.
- Knowledge and experience with statistical software.
- Ability to problem solve and work on your own initiative.
Team & Environment
You will report directly to the Analytical Development Manager, contributing to a team dedicated to high-quality scientific work within a global organization.
Work Mode
This position is a full-time, onsite role at our Ballina, Co. Mayo, Ireland facility.
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