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Job id: 090705. Salary: £43,205 per annum, including London Weighting Allowance.

Posted: 06 June 2024. Closing date: 27 June 2024.

Business unit: Faculty of Life Sciences & Medicine. Department: Gene Therapy and Regenerative Medicine.

Contact details: Kinga Nowicka. kinga.nowicka@kcl.ac.uk

Location: Guy's Campus. Category: Professional & Support Services.

THIS VACANCY IS OPEN TO INTERNAL APPLICANTS ONLY

About us

The KCL Centre for Gene Therapy & Regenerative Medicine (CGTRM) in collaboration with the KCL Gene Therapy Vector Facility (GTVF) 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.

In 2021 MRC/LifeArc/BBSRC 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.

About the role

This role is for a qualified and experienced Senior Technical Scientist 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.

You will contribute to the plan to deliver technical innovation and lead 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 and 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 but not essential.

This post will be offered on a fixed term contract until 31 December 2025.

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

About the role

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

  1. Level 6 qualification, e.g. relevant undergraduate degree or equivalent, 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
  2. Comprehensive background in analytical methods development, hands-on experience in aseptic handling, cellular and bioprocessing techniques, analytical methods optimisation and development and process validation
  3. Knowledge and experience of GMP standards in developing analytical methods 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. Comprehensive knowledge of wide range of analytical technics and scientific practice and the theory underpinning these technologies
  4. 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
  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
  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
  7. Excellent planning, organisational and leadership skills. Competent in managing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products
  8. Excellent communication skills, influencing/behaviour skills and record keeping. 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
  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

Desirable criteria

  1. Experience in supporting quality and/or manufacturing team for implementation of electronic quality documentation and electronic batch Experience in process development, manufacturing and release of viral vector products
  2. 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
  3. Able and willing to provide support beyond core hours, as required

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “Apply Now”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further information

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers will review your application, please take a look at our ‘How we Recruit’ pages.

We are able to offer sponsorship for candidates who do not currently possess the right to work in the UK.