Project Leader

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

For 75years, 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.

Job Overview

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

This role will report to the Analytical Development Manager, and the main duties & responsibilities will be:

• Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
• Ensure all new methods are validated in accordance with ICH 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.

• Degree in relevant science discipline (e.g. Chemistry, Biochemistry Biotechnology, Immunology, Pharmaceutical Sciences, and Molecular Biology ), PhD is preferred but not mandatory.
• A minimum of 3 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, assay development, optimization, ICH analytical validation and project management.
• Ability to project manage multiple studies.
• Knowledge and experience with statistical software.
• 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.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.