Job Description

Description

The purpose of this role is to support the activities of the CGT Catapult's GMP Quality Control Laboratories and associated infrastructure. Reporting to the Quality Control Lead, this role will help ensure that the CGT Catapult Manufacturing Innovation Centres in Stevenage (SMIC) and Braintree (BMIC) meets the standards and expectations of its key stakeholders, regulatory authorities, and existing and potential new Collaborators.

Key Responsibilities

QC Service Delivery - Environmental monitoring / microbiology:Serve as the first point of escalation in the event of Out of Specification (OOS) and Out of Trend (OOT) results Assist in the execution of validation protocols and data reporting associated with microbiological testing, e.g., Bioburden assays Ensure processes and workflows are adhered to by the EM team. Perform routine viable and non-viable environmental monitoring in classified areas of the CGT Catapult MICs Perform laboratory analysis and result reporting to assure service provision associated with viable environmental monitoring, excipient, in-process, final product sample testing and raw material approval is maintained in line with the requirements of each Collaborator and across the CGT Catapult MICs Complete the testing as per GMP requirements Review data for accuracy before submission to Collaborators Perform testing for biosafety e.g., detection of mycoplasma by PCR, detection of endotoxin, detection of microbial contamination by direct inoculation, detection of microbial contamination by BacT/Alert As required work with the QC and QA teams, suppliers and service providers, to assist in the development and maintenance of GMP compliant QC Laboratory services across the CGT Catapult MICs Undertake additional hours (including weekends and bank holidays) to meet operational demand Willingness to travel to other CGT Catapult sites to support CGT Catapult MIC laboratory operations as required QC Sample Management & LIMS Management Support the Sample Management function to ensure the QC group provides a timely, effective, and efficient service for the collection (from manufacturing modules and other classified areas), transportation, storage and lifecycle management of Collaborator and CGT Catapult derived microbiology and environmental monitoring samples requiring testing Support Collaborator raw material sampling activity and ensure it is undertaken to GMP and in accordance with Collaborator requirements
Microbiology:Lead microbiological out of specification investigations Support the implementation of new methods for performing speciation in-house Act as a subject matter expert for environmental monitoring, plate reading and speciation Support other testing needs as identified from time to time by Collaborator Agreements Complete routine record review of test data and related documents Assist in training team members on microbiological test methods including EM Report any equipment related issues to QC Laboratory Compliance Manager
Regulatory Compliance:Provide support to ensure that the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards Provide support to ensure that all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity) Ensure accurate, timely, and GMP-compliant completion of all documentation and records by the CGT Catapult team and associated service providers Maintain full traceability of all reagents, materials, equipment, and standards used in GMP sampling and testing activities Lead Out of Trend, Out of Specification and Deviation management events associated with QC activity and reporting and managing such events to an appropriate and compliant conclusion

Experience:

Proven experience working in microbiology or in an aseptic (bio)pharmaceutical manufacturing environment operating within a GMP environment Experience in managing OOS and OOT reports, including conducting thorough root cause analyses Track record of critically evaluating work practices, both own and others, and implementing improvements to enhance quality and efficiency

Skills, Knowledge and Expertise

Highly motivated, pragmatic, and practical to support the mission of the CGT Catapult to assist in the acceleration of the development of a commercial cell-based therapy industry in the UK Demonstrated ability to conduct laboratory investigation reports in compliance with regulatory standards Self-motivated with excellent interpersonal, communication and presentation skills and the ability to prioritise effectively and work to tight deadlines A "roll your sleeves up" hands-on attitude towards varying work assignments Resilient, with the ability to manage multiple and varied tasks and prioritise workload for self and others within a fast-paced professional environment, with a strong attention to detail Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks Ability to solve problems and make informed decisions Excellent technical writing skills and a high level of attention to detail Project ownership and pride in its delivery Having a passion for delivering excellent customer service Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives Ability to quickly establish credibility and build rapport and trust A good team player with a hands-on approach, and adaptable to new challenges A positive attitude towards learning, personal and professional development Keeps up to date with professional knowledge, expertise and best practice Willingness to travel

Education / Qualifications:

Bachelor's degree in microbiology, Biotechnology, Molecular Biology, or a related Scientific discipline

About Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult (CGT Catapult) is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector.

With experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation.

The Cell and Gene Therapy Catapult works with Innovate UK.

CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone's contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.