Senior Technical Officer - Process Development

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.

About the role

This role is for a qualified and experienced Scientist who has been working in an academic or commercial research laboratory/ company related to the development, manufacturing and purifiying viral vectors (lenti, retroviral) or other gene therapy products as IMPs.

The post holder 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/ knowledge of viral vectors and purification methods and excellent interpersonal skills to work within and across diverse teams.   

Additional experience in associated technologies, such as the use of bio-reactors, and concentration technologies for the production of viral vectors are essential.

This post will be offered on a fixed-term contract until 30th Sept 2026 in the first instance.

This is a full-time post.

About you

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

Essential criteria

• 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
• Expertise in molecular biology in cloning, PCR and viral vector expression. Comprehensive background in purification methods development, hands-on experience in aseptic handling, cellular and bioprocessing techniques, analytical methods optimisation and development
• Comprehensive knowledge of wide range of analytical techniques and scientific practice and the theory underpinning these technologies. 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 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
• 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
• Competent in managing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products
• 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

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