<!--anchor--> <!--anchor--> Senior GMP Quality Control Technician <!--anchor-->

Role Purpose

The Ocular Cell and Gene Therapy group (OCGT), in the Centre for Gene Therapy and Regenerative Medicine (CGTRM), develops a wide variety of novel cell and gene therapies for the treatment of neurodegenerative diseases, with a particular emphasis on retinal disease.

This is an exciting opportunity to work at the interface of basic and clinical research in a group that is at the forefront of developing novel therapies for retinal disorders, with a major emphasis on translating research into clinical application. Led by Professors Robin Ali and Rachael Pearson (previously at UCL’s Institute of Ophthalmology), it is one of the largest cellular therapy groups in the country and is currently expanding. Over the past 20 years, the group has been optimising cell transplantation to the eye to develop novel therapeutic approaches for eye disease and in particular for disorders affecting the retina, including inherited retinal degeneration. The programme has already led to first-in-human clinical trials of gene and cell therapy for eye disease and we are now in the pre-clinical development phase for clinical trials for photoreceptor cell therapy.

This role is for a qualified and trained GMP Quality Control Technician who has been working in the Quality Control department related to analytical development, validation, testing and release of cell-based products as IMPs in an academic or industry-led GMP manufacturing facility. The work will include day-to-day execution of QC testing operations, ensuring the schedule is followed by participating in QC assay development, validation, testing and release processes, liaising with the quality and technical teams, preparing of GMP compliant documentation, identifying bottlenecks and reporting to the Production Manager and Academic leads. In fulfilling these tasks, a strong background in cGMP, analytical testing/validation and good interpersonal skills will be essential, but training (both in-house and through external courses) will be provided, as deemed necessary.

Role profile

As part of the role profile, the GMP Quality Control Technician will be required to participate in initial site start-up activities related to facility and equipment qualification, process/QC validation activities leading to site readiness and GMP inspection of the cell therapy manufacturing facility including implementation of electronic quality system and batch record documentation and be trained in the manufacturing and release of cell therapy products. Further, the post holder may be required to support other projects within the OCGT group and will design and execute experiments independently or in collaboration with other group members, as required by managers.

The postholder will have sufficient expertise working in a GMP licensed facility and be competent in molecular, cellular and analytical techniques, QC development, validation of quality control assays for in-process, stability and release testing including processing of samples for Crude Bulk Harvest, Drug Substance & Drug Product, including stability testing. They will have experience in ensuring compliance to pharmaceutical quality system, interacting with quality assurance, compiling laboratory reports and ensuring QC testing as per product specification file, reviewing electronic quality records for quality approval, batch certification and QP release. They will be trained in and have experience of performing assigned duties within a team and interacting with QC staff performing analytical testing (QC assay development and validation) operations, for process/analytical assay optimisation and development, validation, manufacturing, QC testing and release of products for clinical trials.

This post will be offered on a fixed-term contract for 24 months in the first instance

This is a full-time post - 100% full time equivalent

Key Objectives:  

•                  Plan, develop & execute QC procedures for implementation and approval for cGMP compliance. Set high quality standards for service and execution to ensure GMP compliance.   

•                  Demonstrate a commitment to ongoing professional development, complete own periodic staff qualification and training records related to manufacturing procedures. Engage in and undergo relevant training. 

•                  Help manage periodic staff qualification and training records related for testing of development, pre-clinical and GMP batches.  

•                  Assist, supervise and train staff in relevant hands-on activities related to staff qualification, and perform routine activities for QC assay development and validation for QC release testing and stability testing.  Set goals for achieving project aims and manage progress. 

•                  Assist in the planning and execution of site start up activities to include facility and equipment qualification, qualification procedures for cleaning and disinfection, environmental monitoring and decontamination operations for GMP compliance, analytical development and validation activities and transfer of analytical procedures to third party sponsors 

•                  Pro-actively support the team in the development and execution of electronic quality assurance operations related to GMP compliance, electronic design history records and supplier management system. Implement new technological approaches by incorporating quality risk management principles in all aspects to ensure product quality, patient safety and GMP compliance. 

•                  Pro-actively support team responsible for ensuring timely execution and completion of QC assays for in-process, release and stability testing throughout the GMP manufacturing process.  

•                  Liaise with management team to solve problems that impact on the achievement of OCGT objectives and deadlines and contribute actively to decisions affecting performance and meeting objectives.   

•                  Provide cover in the absence of key production staff.   

•                  Manage own workload and resources based on an agreed work plan for achievement of project aims whilst also being responsive to changing priorities. 

•                  Maintain up-to-date, accurate and comprehensive documentation records and laboratory reports related to execution and completion of all activities starting from site start-up to testing and release.         

•                  Communicate complex information in a clear and precise way, both orally and in writing, to key stakeholders and prepare reports for presentations, seminars, national or international meetings. Attend and contribute to team meetings for periodic review and progress 

•                  Be an active member of King’s Technical Network, engaging in cross-King’s initiatives and building a strong network across the organisation to strengthen and facilitate best practice used by the services

•                  Participate in cross-School/Faculty/University projects as agreed with the line manager

•                  Pro-actively interact with and contribute to collaborative decision making with internal and external stake-holders including suppliers/ contractors to ensure timely implementation and execution of all services to ensure quality standards, manufacturing schedule and regulatory compliance. 

•                  Support staff in the conduct of individual and collaborative research projects, as required by OCGT management, including analysing and interpreting research data and draw conclusions on the outcomes. 

•                  Engage in Continuing Professional Development and training initiatives, in line with the Technician Commitment and Research Concordat for a minimum of 10 days pro rata per year. Continually update knowledge and understanding in field of cell therapy.  

•                  Be responsible for the compliance with Health & Safety and other relevant regulations governing the work. Complete risk assessments, adjusting protocols and facilities, ensuring GMP compliance at all times, to reduce the level of risk including negative environmental impacts.

•                  Demonstrate leadership and innovation in the implementation of environmentally sustainable practices, recording progress through the King’s sustainability audit process and sharing good practice. Nurture and encourage sustainable practices and leadership within your team and networks.

•                  Facilitate an inclusive culture and ethos working with academic, research and other professional services staff and colleagues external to King’s.

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post. 

Essential criteria  

Qualifications and Training

1.      Minimum level 6 qualification, e.g. relevant undergraduate degree or equivalent, in Biological discipline related to life sciences OR equivalent experience, with significant GMP training and ATMP QC testing experience for the release of cell therapy products as IMPs/INDs for clinical trials (AP, I). 

2.      Strong background in analytical cellular and molecular techniques, and trained as Quality Control Technician or Scientist for GMP manufacturing, leading to release of cell therapy IMPs/ MS products in a licensed GMP facility in university or industry (AP, AP/I) 

3.      Trained in QC optimisation and development, analytical assay development, analytical validation, analytical testing of MCB/WCB cell therapy products for pre-clinical and clinical trials in a reputed academic organisation or industry (AP/I). 

Skills / Experience

4.      Experience in QC related operations in a licensed GMP facility with a good working knowledge of regulations and best practice governing cGMP compliance including qualification of staff and equipment, in addition to approved QC procedures for use in GMP manufacturing and product release (AP/I). 

5.      Experience in working with quality team ensuring document control, training records, validation including calibration and maintenance, audit, change control, deviations, CAPA, OOS, quality risk management, supplier qualification and approval, etc are in compliance with PQS (AP/I).  

6.      Experience in i) development and qualification of QC assay procedures for in-process and QC product release testing, ii) preparation for internal, external and regulatory audits, and executing operations leading to GMP inspection readiness and approval (AP/I). 

Knowledge

7.      Working knowledge of EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, current MHRA Orange Guide  including EU GMP regulations for ATMP manufacturing for clinical trials (AP, I) 

8.      Knowledge in compiling QC Validation Master Plan covering aspects of in-process, internal and external QC testing requirements as per Ph.Eur guidelines, and Batch Manufacturing Record for QP review and release (I).  

9.      Knowledge of the field of cell therapy, and expertise in translational research methodology with an organised and systematic approach to development and manufacturing (I). 

Competencies

10.   Trained in relevant analytical cellular and molecular techniques for testing and release of cell therapy products (AP/I). 

11.   Competent in managing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products (I). 

12.   Clear spoken & written communication skills and influencing/behaviour skills to build strong networks with internal and external stake-holders, good record keeping and attention to detail, ability to contribute to the team success, including helping to  train colleagues, providing scientific input during meetings, keeping a healthy working atmosphere in the lab and GMP facility (I). 

Desirable criteria

1.      Experience in supporting quality control and assurance team for implementation of electronic quality documentation (AP, I). 

2.      Experience in analytical development, testing and release of cell therapy products in ongoing clinical trials. 

3.      Experience in GMP facility start-up from facility and equipment qualification to development, validation and testing, and handling cell therapy projects successfully from pre-clinical testing to batch release, CMC documentation and IMPD/IND approval (AP, I).  

4.      Experience in working with quality control team comprising of development, QC and quality assurance staff for coordinating milestones related to quality assurance, process and QC development, audits (internal, external and regulatory), and successful interactions with internal and external stake holders, leading to GMP inspection readiness and approval (AP, I). 

5.      Experience in working with a team to meet agreed timelines for testing and release of cell therapy products for clinical trials, providing support beyond code hours when required (AP, I).