Location
London

Hours
Full Time

Salary
£73,496 per annum

About the Role
Guy’s and St Thomas’ NHS Foundation Trust is one of the UK’s busiest and most successful NHS foundation trusts, providing a full range of hospital and community services across south London and specialist care for patients from further afield. The Trust is renowned for clinical excellence, high quality teaching, and world-leading research, with dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit. The Trust is part of King’s Health Partners, one of eight accredited UK academic health sciences centres.

The Head of Advanced Therapies Production will manage production activities within the GMP Unit, leading the development and production of current manufacturing campaigns and new manufacturing processes. This role includes managing infrastructure, systems, and procedures to ensure compliance with UK and Trust requirements, developing and implementing policies and standard operating procedures, and collaborating with the Head of Quality on quality assurance of the GMP Unit.

The post holder will oversee day-to-day management, operation, scheduling, and administration of production processes, ensuring compliance with licensing requirements and that all products are manufactured and stored according to guidelines to ensure safety and quality. This role also involves line management responsibilities, training delivery, procurement in line with GMP and Trust processes, and representing the Trust at national and international meetings to promote the Unit’s work and build new business opportunities.

The R&D Department at Guy’s & St Thomas’ is a focal point for innovative research in London, with strong strategic partnerships and a nationally recognised research portfolio. The Trust leads in NIHR portfolio studies and commercial clinical trials, supporting a vibrant research environment.

Experience
- Considerable experience managing production, qualification, quality, and documentation activities in a GMP environment
- Proven ability to manage complex production schedules and ensure efficient record keeping
- Extensive supervisory experience, including leading, developing, motivating, and managing a team of production scientists
- Strong project management skills
- In-depth understanding of cell therapy processes such as purification, culture, expansion, and genetic modification using viral vectors, regulatory T cells, ES Cells, and other non-adherent cells
- Experience with unit processes including MACS, FACS, bench scale centrifugation, density gradient centrifugation, cell expansion in closed systems, and purification and formulation of ATMPs
- Budget management experience

About You
- Resilient and flexible with the ability to contribute innovatively to solving process development problems
- Well motivated and able to work independently using own initiative
- Able to develop and maintain good working relationships at all levels
- Highly professional, especially when handling confidential information
- Strong communication skills, both verbal and written, including report writing and presentations to senior staff
- Strong organisational skills with the ability to manage competing demands
- Commercially aware with experience managing procurement and contracts
- Good computer skills

Qualifications
- Essential: Postgraduate degree (MSc or equivalent experience) in an appropriate subject area
- Desirable: PhD or equivalent qualification

Desirable Experience and Skills
- Knowledge of tissue engineered products
- Experience with dissolution, sterilisation by filtration, small scale manual aseptic filling, small scale chromatography, micro and ultrafiltration
- Experience with computerised Document Management systems such as Q-Pulse
- Support for expansion or modification of existing GMP infrastructure
- Familiarity with 20L disposable bioreactors and hand filling into vials
- In-depth knowledge of MHRA, HTA, and HSE legislative frameworks related to GMP for small scale biopharmaceutical production
- Knowledge of Good QC Laboratory Practice and routine in-process controls and QC assay techniques such as flow cytometry, sterility testing, mycoplasma testing, ELISA, NAT/PCR assays