Biologics Manufacturing Operator - Downstream Keele, England
Job description
Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.
- The manufacture of clinical and commercial products in accordance with EU GMP / FDA regulations
- To form part of multidisciplinary teams in a cleanroom production environment
- To support and maintain the status of the GMP production facility clean rooms.
- Compliant execution of GMP processes according to Manufacturing Plans and Batch Manufacturing Records.
- Ensure production logbooks and Batch Manufacturing Records are completed and maintained according to Charles River Standard Operating Procedures.
- Prepare, review and revise production documentation (eg Standard Operating Procedures, Material Specification Sheets)
- Ability to work using good aseptic technique
- Knowledge in the use of standard clean room equipment including, peristaltic pumps, balances and pH meters.
- Escalation and reporting of non-conformance events
- Contribute to continuous improvement and investigations as part of the Quality Management System.
- Experience of Downstream processing operations, including Buffer Preparation, Filtration and Chromatography is desirable.
You will be educated to A level or equivalent, a BSc or equivalent degree level qualification is desirable. Candidates who do not have academic qualifications but can demonstrate extensive relevant experience in this area will be considered.
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
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.