Experienced GMP Operator - DSP

Req ID:  174811
Location: 

Keele, GB, ST5 5SP

For 70 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 for an additional experienced GMP Operator to support the growth of our Product Delivery team. 

Profile and Requirements

 

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 Cobra 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

 

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.
 

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 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 2018, revenue increased to $2.67 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.