Job description
 
The Centre for Cell and Gene Therapy (CCGT) manufactures ATMPs for a wide variety of novel gene and cell therapies for the treatment of cancers to rare diseases. This is an opportunity to work within one of the largest academic GMP facilities in  Europe focusing on the delivery of gene therapy products for early phase clinical trials.
This role is for a qualified and trained Senior GMP Quality Control Technician who has been working in a supervisory role in the Quality Control department related to analytical development, validation, testing and release of AAV vectors or other gene therapy products as IMPs in an academic or industry-led GMP manufacturing facility. The work will include day-to-day management 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 team, preparing of GMP compliant documentation, identifying bottlenecks and reporting to the Head of Quality (or QC Manager). In fulfilling these tasks, a strong background in cGMP, analytical testing/validation and interpersonal skills will be essential, but training (both in-house and through external courses) will be provided, as deemed necessary.
 
As part of the role profile, the senior 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 AAV vector manufacturing facility including implementation of electronic quality system and batch record documentation, and be trained in the manufacturing and release of gene therapy products at Guy’s or Denmark Hill campus. Further, the post holder may be required to support other projects within the CCGT group, and will design and execute experiments independently or in collaboration with other group members, as required by manager or head.
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 be competent 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 competent working with supervising their team and interacting with QC staff performing analytical testing (QC assay development and validation) operations, covering the different stages of product life cycle from vector design, plasmid specifications, process/ QC optimisation and development, validation, QC testing, stability assays and delivery of products to clinical trial sites.
 
This post will be offered on a fixed-term contract for 30 months in the first instance 
This is a full-time post - 100% full time equivalent

Key responsibilities
 

• Undertake original and state of the art translational biomedical research and performing QC testing as an integral member of CCGT working on the development and release of cell and gene-based therapies.
• Plan, develop & execute QC procedures for implementation and approval for cGMP compliance. Adhere to PQS and set high quality standards for service and execution to ensure GMP compliance. 
• Manage periodic staff qualification and training records related for testing of development, pre-clinical and GMP batches. Actively identify and arrange relevant training, including the use of validated analytical equipment,  for self and facility staff in accordance with approved Training Matrix and as required for GMP compliance.
• Assist, supervise and train staff in 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 and actively identify areas for development and improvement.
• Lead 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 
• Support the quality team in the development and execution of electronic quality assurance operations related to Pharmaceutical Quality System 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.
• Plan, guide and support team responsible for ensuring timely execution and completion of QC assays
• Support the development department to ensure testing of development and pre-clinical batches and communicating with key stake-holders. Actively participate as a core member of the team for in-process, release and stability testing.
• Provide cover in the absence of key production staff. 
• Maintain up-to-date, accurate and comprehensive documentation records and laboratory reports, where applicable. 
• Lead and prepare 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
• Support the preparation of manuscripts for publication in peer review journals or book chapters
• 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 service. 
• 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.
• Take independent decisions in a timely manner to solve problems that impact on the achievement of CCGT objectives and deadlines, informing management where necessary, and contribute actively to descitions affecting performance and meeting objectives. 
• Support staff in the conduct of individual and collaborative research projects as required by CCGT 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 and gene 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.
 
A more comprehensive overview of the key responsibilities may be requested from Heather Kneale – heather.kneale@kcl.ac.uk .  
 
Skills, knowledge, and experience 
 
Essential criteria  
 
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 substantial ATMP QC testing experience for the release of viral gene therapy products as IMPs/INDs for clinical trials (AP, I). 
2.       Strong background in analytical cellular and molecular techniques, and trained as senior Quality Control Technician or Scientist for GMP manufacturing, leading to release of gene/cell therapy IMPs/ MS products in a licensed GMP facility in university or industry (AP, I) 
3.       Trained in QC optimisation and development, analytical assay development, analytical validation, analytical testing of MCB/WCB, gene/cell therapy products for pre-clinical and clinical trials in a reputed academic organisation or industry (I). 
 
4.       Comprehensive knowledge of regulations and best practice (including Helath & Safety & environmental sustainability) governing  QC operations in a licensed GMP facility ensuring cGMP compliance including meeting regulatory expectations for qualification of staff, equipment, in addition to approved QC procedures for use in GMP manufacturing and product release (I). 
5.       Significant 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.       Broad experience in  development and qualification of QC assay procedures for in-process and QC product release testing, preparation for internal, external and regulatory audits, and executing operations leading to GMP inspection readiness and approval (I). 
 
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.       Good knowledge of the field of gene and cell therapy, and expertise in translational research methodology with an organised and systematic approach to development and manufacturing (I). 
 
10.   Skilled in relevant analytical cellular and molecular techniques for testing and release of gene therapy vectors (I). 
11.   Competent in managing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products (I). 
12.   Excellent spoken & written communication skills and influencing/behaviour skills to build strong networks with internal and external stake-holders, 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.       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 AAV gene 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 AAV gene therapy projects successfully from pre-clinical testing to batch release, CMC documentation and IMPD/IND approval (AP, I).  
4.       Experience in managing the quality control team and working with a 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 motivating and performing team to meet agreed timelines for testing and release of gene therapy products for clinical trials (AP, I).