QC Specialist - FTC in Stevenage

The Quality Control Specialist will support the activities of CGT Catapult’s GMP Quality Control Laboratories and associated infrastructure and will help ensure that the CGT Catapult Manufacturing Innovation Centres (MICs) in Stevenage and Braintree meet and operate to the standards and expectations of its key stakeholders, regulatory authorities, and potential Collaborators.

Key Responsibilities

• QC Service Support – e.g. Environmental monitoring, microbiology, testing of raw material, in-process material tests, final product testing etc.
• Support the tactical execution of laboratory analysis and result reporting to ensure the QC service provision is maintained in line with the requirements of each Collaborator.
• Lead technical transfer, validation and routine execution of analytical techniques used for the manufacture, testing, and release of cell and gene therapy products, including flow cytometry, qPCR, ddPCR, ELISA.
• As required work with the wider QC team, QA, suppliers and service providers to assist in the development and maintenance of GMP compliant QC Laboratory services and systems.
• Prepare, review and report process trending charts for QC activities.
• Undertake non-guaranteed overtime as per the Company policy in response to an operational need.

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, transportation, storage and lifecycle management of Collaborator and CGT Catapult derived microbiology and environmental monitoring samples, and manufacturing process and drug substance/product samples requiring testing.
• Support Collaborator raw material sampling activity and ensure it is undertaken to GMP standards and in accordance with Collaborator requirements.
• Support the continued use and configuration, as required, of the electronic laboratory information management system (LIMS) in accordance with the requirements of GMP.
• Leadership and line management supporting a growing group of QC Technicians.
• Manage QC scheduling and resource allocation ensuring efficient operation.

QC Service

• Conduct test verifications and analytical method qualifications as required.
• Provide support for aseptic process qualifications, e.g. aseptic gowning, good aseptic practices and media fills etc.
• Conduct Out of Specification and other laboratory investigations.
• Provide training and guidance to the QC team and oversee routine activities to ensure the services are delivered in compliance with GMP standards and other QMS elements.

Regulatory Compliance

• Provide support to ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.
• Provide support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
• Generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc. in compliance with applicable regulatory requirements for the service.
• Provide support to ensure the CGT Catapult QC team and associated service providers complete all documentation and records accurately, contemporaneously, and to a consistent GMP standard.
• Provide support to ensure the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity.
• Lead Change Controls, Out of Trend, Out of Specification and Deviation management events associated with QC services and assist in the implementation, reporting and management of such events to an appropriate and compliant conclusion.

Experience

• Proven experience working in microbiology or in an aseptic (bio)pharmaceutical manufacturing environment, operating according to GMP, at similar responsibility level.
• Demonstrable experience of writing, executing and reviewing GMP documents and processes, including validations, autonomously.
• Proven experience of working in grade B/C cleanroom in a GMP facility.
• Demonstrable experience with relevant laboratory test platforms including operation and troubleshooting e.g. ELISA, Endotoxin testing, Sterility testing, Flow Cytometry, qPCR, ddPCR, Cell viability testing etc. in a commercial setting.
• Demonstrable experience with interacting with the regulatory authorities would be desirable.
• Demonstrable experience with interacting with clients and collaborators would be desirable.

Knowledge / Skills / Competencies

• Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK.
• Motivation to build a career in the cell and gene therapy sector and contribute to its commercial success.
• Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment, whilst maintaining a high standard of work and meeting deadlines.
• High level interpersonal and communication (oral and written) skills, with the ability to engage and influence stakeholders, build rapport, establish credibility, and apply diplomacy across diverse internal and external groups.
• Accurate with strong attention to detail.
• Strong organisational skills with a sense of ownership and accountability for project delivery.
• Project ownership and pride in its delivery; strong organisational skills.
• Having a passion for delivering excellent customer service.
• Flexible and adaptable to changing priorities, work assignments, and new challenges.
• Ability to work independently, take initiative, and operate autonomously once objectives are set, including under pressure.
• Ambitious, collaborative, driven.
• Understanding of appropriate use of escalation processes.
• Proficient in Microsoft 365 applications and general IT systems.
• A positive attitude towards learning, personal and professional development.
• Keeps up to date with professional knowledge, expertise and best practice.
• Willingness to travel as required by the role.

Education / Qualifications

• Bachelors or higher degree in relevant biology subject.