Batch Release Co:Ordinator
ballina, Ireland 4 days ago
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 Summary
We are seeking an experienced Batch Release Co:Ordinatorfor our Biologics Division located inBallina, Co. Mayo, Ireland.
This role shall report to the Analytical Functional Manager and the main duties and 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 thisPosition;
: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 perspec
Batch Release Co:Ordinator
ballina, Ireland 4 days ago
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...
Batch Release Co:Ordinator
ballina, Ireland 1 month ago
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...