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 experienced  Senior GMP Production Technician who has been working in a supervisory role in the Production department related to the development and manufacturing or testing and release of AAV (adeno-associated viral) 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 GMP production runs, ensuring the schedule is followed by participating in process development, validation and manufacturing processes, liaising with the quality and technical team, preparing of GMP compliant documentation, identifying bottlenecks and reporting to the Senior GMP Production Manager. In fulfilling these tasks, a strong background in GMP 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 Production 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 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 aseptic techniques and cell culture, process development and manufacturing. They will be competent in ensuring compliance to pharmaceutical quality system, interacting with quality assurance, compiling laboratory reports and product specification file, reviewing electronic batch manufacturing records for quality approval, batch certification and QP release. They will be competent working with supervising their team and interacting with: (i) Production staff performing upstream processing (thawing to crude bulk harvest), downstream processing (bulk purification to final vialed product), covering the different stages of product life cycle from vector design, plasmid specifications, process optimisation and development, validation, manufacturing of products for clinical trials.
 
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 manufacturing as an integral member of CCGT working on the development and release of cell and gene-based therapies.
• Plan, develop & execute manufacturing procedures for implementation and approval for cGMP compliance. Adhere to PQS and set high quality standards for service and execution
• Undertaking and manage periodic staff qualification and training records related to manufacturing or quality procedures including operations related to gowning, process simulation for batch manufacturing and final product filling. Actively identify and arrange relevant training, including the use of validated manufacturing or analytical equipment, for self and staff in accordance with the approved Trainign Matrix.
• Assist, supervise and train staff in hands-on GMP operations related to qualification, aseptic techniques, cell culture, viral product harvest, purification, formulation and final product filling for Production operations. Set goals for achieving project aims and actively identify ares for development and improvement.  
• Lead in process development & validation activities and in the planning and execution of site start up activities to include facility & equipment qualitification, qualification procedures, environmental monitoring and decontamination. 
• Lead in technology transfer for manufacturing or analytical procedures and scale-up of manufacturing and purification processes. 
• Maintain up-to-date, accurate and comprehensive documentation records and laboratory reports, where applicable. 
• 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 to ensure product quality, patient safety and GMP compliance.
• Provide support to colleagues responsible for ensuring compliance of clean room preparation, quarantine procedures and process and release testing. 
• Lead on preparation of laboratory reports related to execution and completion of all activities starting from site start-up to GMP manufacturing and release.
• Provide cover in the absence of key production staff.  
• Communicate complex information in a clear and precise way, both orally and in writing, to key stakeholders in QC including QA Manager, Head of Quality and QP 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 interactive 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 in the analysis & implementation of development, manufacturing and testing objectives and proposals for execution of project timeline in accordance with approved quality plan and PSF.
• 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 and/or Engineering discipline related to life sciences OR Considerable knowledge and skills gained through work experience in a relevant post, demonstrating development through progressively more demanding work (AP, I). 
2.       Strong background in bioprocess engineering, hands-on experience in aseptic handling, cellular and bioprocessing techniques, bioprocess optimisation and development and process validation (AP, I) ,  
3.       Significant GMP training with substantial experience in manufacture of viral gene therapy products as IMPs/INDs for clinical trials  for pre-clinical and clinical trials in an academic organisation or industry (I). 
 
4.       Comprehensive knowledge of regulations and best practice (including Health & Safety and environmental sustainability) governing operations in a licensed GMP facility ensuring cGMP compliance including meeting regulatory expectations for qualification of staff, cleanroom and equipment, in addition to approved manufacturing 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 (i) aseptic techniques related to cell culture, product harvest, product purification, 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). 
 
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 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 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 cellular, molecular and bioprocess techniques for manufacturing and testing 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 process development, manufacturing and release of AAV gene therapy products.(AP, I) 
2.       Experience in managing the production team and working with a team comprising of development, production and quality assurance staff for coordinating milestones related to quality assurance, manufacturing, audits (internal, external and regulatory), and successful interactions with internal and external stake holders, leading to GMP inspection readiness and approval (AP, I). 
3.       Able and willing to provide support beyond core hours, as required.