Advanced Therapy Production Scientist

Position

The Advanced Therapy Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital on the 15th floor of the tower. This purpose-built unit manufactures Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue‑engineered products for early‑phase clinical trials. The unit serves both commercial and non‑commercial clients and supports GSTFT and KCL departments for trials undertaken in the CRF and at sites across the UK.

The role offers a unique opportunity to work at the interface between science and clinical medicine, creating and implementing key production documents including Product Specification Files, Batch Manufacturing Records and Standard Operating Procedures.

• Lead in the manufacturing of advanced therapy medicinal products
• Ensure that the unit is always well‑stocked
• Ensure receipt of raw materials and release as set out in policies
• Work with engineers to maintain planned maintenance of the unit
• Write and review instrument‑ or process‑specific SOPs and other documents
• Perform qualification duties on instruments and processes for manufacture of ATIMPs
• Assist production with academic collaborator scientists
• Ensure that the products manufactured are labelled, documented and stored according to product specification and quality standards
• Perform cell isolation using magnetic sorting or fluorescent sorting within a GMP environment
• Carry out closed‑system cell culture and activation
• Apply flow cytometry and proliferation methodologies
• Conduct cell transduction using different viral vectors
• Collaborate with internal and external partners
• Scale up work within the GMP unit to optimise procedures
• Perform process validation work such as engineering runs
• Execute equipment validation work as required for different clinical trials
• Maintain, operate, and clean the GMP unit’s equipment and unit
• Qualify, process validate, and re‑validate equipment and GMP procedures successfully
• Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained