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.
Job Summary We are currently looking to recruit a Quality Control Microbiologist within the QC Department at our site in Keele, Staffordshire.
The successful candidate will be responsible for supporting and participating in the GMP environmental testing regimes within the Manufacturing facility and in related microbiological activities within the QC group.
Profile and Requirements Main duties will include: • Perform water testing and to support full environmental monitoring of the GMP facility.
• Generate data using the methods developed and record it in a way that allows the ongoing status of clean rooms and equipment to be assessed and reviewed • Perform gowning qualification of operators • Perform testing and release of raw materials and equipment for GMP operations • Support fermenter, autoclave and media fill validations.
• To apply standard microbiological methods to characterise cell banks and perform microbial identification • Ensure that all work is carried out safely and in compliance with the requirements of HSE and cGMPs • Report any environmental excursions or other deficiencies promptly in accordance with standard procedures • To ensure GMP compliance is maintained, as defined in the Company Quality system, for all assigned programmes of work both contracted and routine operations • To identify and report quality or compliance deficiencies and suggest remedies You will ideally be educated to degree level or equivalent in a scientific related subject, ideally Microbiology.
Previous GMP experience, knowledge and experience of clean rooms, environmental monitoring and water sampling/testing techniques is desirable, although not essential.
In addition, you will be able to demonstrate strong written, verbal communication skills and practical skills.
This role is office based in Keele, Staffordshire.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past 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.