Batch Release Co-Ordinator
Charles River Laboratories International
Batch Release Co-Ordinator
Ballina, IE, F26D786
For 75 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 Batch Release Co-Ordinator for our Biologics Division located in Ballina, Co. Mayo, Ireland.
This role shall report to the Analytical Functional Manager and the main duties & responsibilities shall be:
- Project Management of routine batch release testing in the Analytical Services Department (client correspondence,/weekly calls, management of subcontractors, ensuring samples are released within the required timelines i.e. scheduling of tests, review of basic data, liaising with QA, generation of CoA etc.)
- Generation of GMP compliant SOPs, Protocols and reports.
- Sourcing, purchasing and stocking consumables, standards and reagents required for testing.
- Receipt and processing of test samples in LIMS
- Carry out data calculations ,basic statistics and trending. Provide additional information at the clients request as required.
- Assist in internal, regulatory and client visits/audits and respond to findings.
- Carry out test method procedures like generic ELISA, MAT assay, microplate assays or client specific immunoassays.
- Safe and compliant disposal of all laboratory generated waste.
Profile and Requirements
The following are minimum requirements related to this Position;
- A minimum of 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Experience in project management essential.
- BSc/M.Sc. in a relevant science discipline (e.g. Analytical Chemistry)
- Experience in analytical techniques/immunoassays desirable but not essential.
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 86% of the drugs approved by the FDA in 2021.
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.