For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

We are seeking an experienced Project Leader for our Biologics Division located in Ballina, Co. Mayo, Ireland.

This role shall report to the Microbiology Department Manager and the main duties & responsibilities shall be:

• Oversee and develop new projects taken on by the Microbiology Department to meet client requirements and/or company strategic objectives.
• Ensure all new projects/methods are transferred/validated in accordance with USP and EP guidelines, where appropriate.
• Draw up study plans and execute studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
• Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
• Responsible for leading laboratory investigations, where necessary.
• Responsible for reporting project progress information to Management.
• Provide technical training to scientific team, as required.
• Day to day liaison with clients regarding current and new projects.
• Involvement with regulatory and client audits.
• Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
• Generate new and update current standard operating procedures.
• Generate risk assessments for various projects as required.

The following are minimum requirements related to the Project Leader position.

• Qualification (PhD, MSc and BSc) in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
• A minimum of 4 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
• Experience in study design, Method development, optimization, Microbiological Method validation and project management.
• Experience in Microbiological techniques (e.g. Aseptic Technique, Sterility testing, Endotoxin testing, Bioburden and Environmental Monitoring etc.) essential.

• Ability to project manage multiple studies..
• Ability to problem solve and work on own initiative.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.