Experienced GMP Operator - Microbial 1

Req ID:  189314

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.


IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

Job Summary

We are currently looking for an additional experienced GMP Operator to support the growth of our Product Delivery team.

Profile and Requirements

The Role
Working within a GMP production environment the role will be varied and will include:

•    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 in the operation of either fixed or disposable fermenters to a 50L scale
•    Ability to work using good aseptic technique
•    Experience in the transformation of microbial electrocompetent cell banks
•    Knowledge in the use of standard clean room equipment including, peristaltic pumps, balances, pH meters, biowelders/sealers and spectrophotometers.
•    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

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.

Proven clean room experience is highly desirable; if you do not have practical clean room experience, you will be able to demonstrate a strong knowledge of GMP. You will also have previous biologics experience, either in an academic or industrial setting. You must be flexible in your approach to work and willing to work additional hours to accommodate processing.  

In addition, you will be fully conversant with Microsoft Office; the enthusiasm to learn and the ability to interact and communicate effectively with colleagues at all levels within the organisation are also essential.

This role will be based at Keele, Staffordshire, however, a willingness to travel within the Group will be required.



IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

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.

With over 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

For more information, please visit www.criver.com.