<!--anchor--> <!--anchor--> Senior GMP Production 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.  

Role profile

As part of the role profile, the GMP Production Technician will be required to participate in initial site start-up activities related to facility and equipment qualification, process validation activities leading to site readiness and GMP inspection of the stem 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.

The work will include day-to-day operations and execution of GMP development and production runs, ensuring the schedule is followed by participating in development, validation and manufacturing processes, liaising with the quality and technical team, preparing GMP compliant batch documentation, identifying bottlenecks and reporting to the Production Manager.

Further, the post holder may be required to take an active role in other projects within the Ocular Cell and Gene Therapy Group, as required by manager or head.

The postholder will have expertise working in a GMP licensed facility and be trained in aseptic techniques and stem cell culture techniques, process development, validation of process for GMP batch manufacturing. They will have been trained in ensuring compliance to pharmaceutical quality system (PQS), interacting with quality assurance, compiling laboratory reports and product specification file, executing electronic batch manufacturing records leading to approval, batch certification and QP release. They will be experienced in performing assigned duties within a team and interacting with Production staff performing upstream processing (thawing to crude bulk harvest) and downstream processing (bulk purification to final vialed product) operations, after completion of process optimisation and development, and process validation for GMP batch manufacturing and release of products for clinical trials.

Further training will be provided, as deemed necessary.

This is a unique opportunity to work in a vibrant translational research environment bridging. The post holder will work in a collaborative team environment with very high potential to learn new skills.  

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

•                      Perform operations related to manufacturing as an active member of OCGT working on the development and release of cell-based therapies.  

•                      Develop and execute manufacturing procedures for implementation and approval for cGMP 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, including hands-on GMP operations related to qualification, aseptic techniques, stem cell culture, cell sorting, formulation and final product filling. Manage training of staff in accordance with approved Training Matrix and as required for GMP compliance. Continually update knowledge and understanding in the field of cell therapy and ATMPS. 

•                      Assist in the planning and execution of site start-up activities related to facility and equipment qualification, qualification procedures, environmental monitoring and decontamination operations, process development and validation activities, technology transfer for manufacturing procedures and scale-up of manufacturing and purification processes. 

•                      Pro-actively support the quality team in the development and timely execution of electronic quality assurance operations related to Pharmaceutical Quality System compliance, electronic design history records, electronic batch records and electronic supplier management system 

•                      Actively support team responsible for ensuring compliance of clean room preparation and quarantine procedures prior to and after GMP manufacturing.  

•                      Support team in the use of validated manufacturing or analytical equipment, providing training where required. 

•                      Assist and support other members of the group, using a systematic and timely approach to solve problems, while handling multiple projects to ensure continued GMP manufacturing and release of cell therapy products. 

•                      Provide cover 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. 

•                      Use well-developed analytical skills to identify trends and patterns, using appropriate techniques and procedures to inform decisions and ensure product quality, patient safety and GMP compliance. Ensure work complies with PQS and set high quality standards for service and execution. 

•                      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. Prepare and submit laboratory reports. Generate and provide data/results for a variety of tasks including presentations at regular GMP lab meetings, seminars, manuscripts, national or international meetings and to support improvement in analytical validation and testing.  

•                      Attend and contribute to team meetings for periodic review and progress 

•                      Actively contribute to decisions affecting performance and in meeting objectives of the team. 

•                      Complete assigned tasks in collaboration with other departments involving key stake-holders in Process Development  

•                      Forge relationships with colleagues in the university and externally, to build relationships, disseminate and get information, coordinate, and deliver the service  

•                      Provide advice/guidance and, where appropriate, training for new staff in the conduct of individual and collaborative research projects. 

•                      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

•                      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 and/or Engineering discipline related to life sciences OR considerable knowledge and skills gained through work experience, with GMP training and ATMP manufacturing experience for the release of cell therapy products as IMPs/INDs for clinical trials (AP, I). 

2.       Background in bioprocess engineering, and hands-on experience in aseptic handling, cellular and bioprocessing techniques, and trained as Production 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, I) 

3.       Trained in bioprocess optimisation and development, process validation, GMP manufacturing of MCB/WCB, cell therapy products for pre-clinical and clinical trials in a reputed academic organisation or industry (I), with a commitment to ongoing professional development 

Skills / Experience

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

6.       Experience in (i) aseptic techniques related to stem cell cultures, cell product handling, formulation and final product filling in a GMP facility, (ii) preparation for internal, external and regulatory audits, executing operations leading to GMP inspection readiness and approval (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.       Awareness or knowledge in compiling Site Validation Master Plan covering aspects of site/equipment validation, calibration and maintenance requirements, Process Validation Master Plan covering aspects of process validation and transfer to GMP Batch Manufacturing Record for QP review and release (I).  

9.       Good 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 aseptic, cellular and bioprocess techniques for development, validation and manufacturing of cell therapy products (I). 

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

12.   Clear spoken and written communication skills, strong interpersonal skills dealing with internal and external stake-holders, good record keeping and attention to detail, ability to contribute to the team success such as training colleagues, providing scientific input during meetings, keeping a healthy working atmosphere in the lab and GMP facility (I). 

Desirable criteria

1.       Competency in working with stem cell-based cell therapy products (AP, I) 

2.       Experience in supporting quality and/or manufacturing team for implementation of electronic quality documentation and electronic batch records respectively (AP, I). 

3.       Experience in process development, manufacturing and release of stem cell-based cell therapy products in ongoing clinical trials. 

4.       Experience in working with production or development team, comprising of development and manufacturing, and quality assurance staff for coordinating milestones related to quality assurance, process development, audits (internal, external and regulatory), and assisted in providing relevant information to internal and external stake holders, leading to GMP inspection readiness and approval (AP, I). 

5.       Willingness and ability to work outside core hours (AP, I)