Senior Technical Officer – Process Development (GMP)
The KCL Centre for Gene Therapy & Regenrative Medicine (CGTRM) develops and 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.
MRC/LifeArc/BBSRC have recently announced the establishment of this Gene Therapy Innovation Hub. One of the main points of focus in the innovation component of the Hub will be the further development of new cell lines and vectors for the GMP compliant manufacture of viral vectors for the treatment of a host of acquired and inherited genetic disorders. The appointee will report to the Head of Process Development/ Senior Research Fellow.
This role is for a qualified and experienced Senior Technical Officer who has been working in an academic or commercial research laboratory/ company related to the development, manufacturing, testing and release of viral vectors (lenti, retroviral, AAV) or other gene therapy products as IMPs. The post holder will contribute to the plan to deliver technical innovation and lead e specified work packages developing the experimental plan with the Head of Process Development and allocating resources to the tasks within the plan. To ensure successful development and translational of the work to GMP manufacture the candidate requires a strong background/ knowledge of GMP and excellent interpersonal skills to work within and across diverse teams.
Additional experience in associated technologies, such as the use of bio-reactors, downstream processing, purification and concentration technologies for the production of viral vectors will be a distinct advantage.
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
• Contribute to and implement the strategy for development of new cell lines, including adaptation of adherent cell lines to serum free suspension growth.
• Contribute to the approach to development of protocols for bio-reactor based culture of suspension cells, and for the manufacture of viral vectors from these cells.
• Contribute to the development plans for process development of lentiviral vectors and lead work packages for the delivery and expression of therapeutic genes to specifically targeted cells.
• Contribute to the evaluation of downstream purification methodologies and technology and lead on allocated work packages to improve the yield and purity of lentiviral vectors.
• 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 experimental plans to determine procedures suitable for implementation in GMP manufacture. Adhere to PQS and set high quality standards for service and execution
• Assist, supervise and train staff in hands-on cell culture, viral product harvest, purification, formulation and final product preparation.
• Contribute to setting goals for achieving project aims and actively identify areas for development and improvement.
• Support the coordination of the process development team & delivery of the work package tasks to realise the objectives of the grant.
• Support the technology transfer process providing subject expertise of the procedures being implemented in GMP manufacturing or analytical testing.
• Maintain up-to-date, accurate and comprehensive documentation records and laboratory reports, where applicable.
• Conduct work in a manner as required by the Pharmaceutical Quality System (PQS) to ensure innovative processes and new technology are implemented by incorporating quality risk management principles to ensure product quality, patient safety and GMP compliance.
• Communicate complex information in a clear and precise way, both orally and in writing, to key stakeholders in Production, Quality and Management team 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 decisions 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.
• Participate in cross-School/Faculty/University projects as agreed with the line manager
• 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 – firstname.lastname@example.org .
Skills, knowledge, and experience
Qualifications and Training
1. Level 6 qualification, e.g. relevant undergraduate degree or equivalent, in Biological and/or Engineering discipline related to life sciences plus substantial work experience in relevant technical/ scientific service post or extensive work experience in relevant technical/ scientific post with management experience and/ or qualification (AP, I).
2. Comprehenisve background in bioprocess development, hands-on experience in aseptic handling, cellular and bioprocessing techniques, bioprocess optimisation and development and process validation (AP, I).
3. Knowledge and experience of GMP standards in developing processes for 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).
Skills / Experience
4. Comprehensive knowledge of wide range of bioprocessing technical and scientific practice covering upstream and downstream technologies and the theory underpinning these technologies (I).
5. Comprehensive knowledge of regulations and best practice (including Health & Safety and environmental sustainability) governing operations in a licensed GMP facility in addition to approved manufacturing procedures for use in GMP manufacturing and product release (I).
6. Experience and knowledge of working within a Pharmaceutical Quality System (PQS) ensuring document control, training records, change control, investigations, CAPA, OOS, quality risk management, supplier qualification and approval, etc are in compliance with PQS (I).
7. Comprehensive knowledge and experience in (i) aseptic techniques related to cell culture, product harvest, product purification, formulation and final product preparation(I).
8. Excellent planning and organisational skills to manage own tasks and supporting the tasks of team members. Excellent leadership skills to lead a team and set performance standards, monitoring the tasks and outputs to ensure successful delivery (I).
9. Comprehensive 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 process and analytical development of protocols which can be transferred to manufacturing and release 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 and professional development of colleagues, providing scientific input during meetings, keeping a healthy working atmosphere in the lab and GMP facility (I).
13. Experience in process development, manufacturing and release of viral vector products.(AP, I)
14. Experience in supervising/advising junior team members and working with multi-disciplinary team across production and quality assurance staff and successful interactions with internal and external stake holders, leading to successful implementation of processes and new technology in manufacturing and testing which can be implement in GMP (AP, I).
15. Able and willing to provide support beyond core hours, as required.