Experienced Biologics Manufacturing Operator

2 weeks ago

Keele, United Kingdom Charles River Laboratories Full time

**Req ID**:218941**Location**:Keele, GB, ST5 5SP- At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
- 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.

**Job Summary**

**Main duties and responsibilities**:

- 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 Standard Operating Procedures.
- Prepare, review and revise production documentation (eg Standard Operating Procedures, Material Specification Sheets)..
- Experience or knowledge of DSP operations, including Column packing, Filtration, Chromatography and TFF.
- 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.
- Ability to supervise a small team in a clean room environment and raise any issues to the batch lead if required
- Aid the senior scientist and production leaders in planning of processes and liaise with other departments as required.
- Training of lesser experienced team members in procedures and standard clean room equipment

**About You**-Previous practical laboratory experience in a relevant technical area in an academic or industrial environment is essential. You will be able to demonstrate strong written, verbal communication skills and practical skills. We are looking for a self-starter, who shows initiative and is a team player, while having the ability to work flexibly to meet the Production needs.
This role will be based at Keele, Staffordshire, however, a willingness to travel within the Group will be required.

**About Corporate Functions**
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.
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.

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