About this role
Job summary
The post holder will be responsible for managing production activities within the Unit and will lead the development and production of the current manufacturing campaigns as well as new manufacturing processes. The post holder will also be responsible for the programme of work centred around managing infrastructure, systems and procedures to ensure compliance with current UK and Trust requirements. This will also include responsibility for developing and implementing policies and standard operating procedures for manufacturing and, along with the Head of Quality, quality assurance of the GMP Unit.
Main duties of the job
The post holder will be responsible for the day to day management, operation, scheduling and administration of the production processes of the GMP Unit ensuring that it is operated and maintained as required by the Unit's licences. The post holder will also ensure that all products are manufactured and stored according to appropriate guidelines helping to ensure products are fit for their intended use with respect to safety and quality.
About us
The R&D Department at Guy's & St Thomas' NHS Foundation Trust (GSTFT) is one of the focal points for innovative research in London through its nationally recognised research portfolio and research infrastructure. We are systems leaders in NHS research with strong strategic partnerships across the National Institute for Health Research (NIHR), Department of Health & Social Care (DHSC) and the Health Research Authority (HRA) and are active members of the organisations such as the Shelford Group, University Hospitals Association (previously AUKUH) and UKRD.
Research is a top priority for the Trust which in 2024/25 was the top NHS organisation nationally for the number of NIHR portfolio studies open (554) and was the 6th highest recruiting Trust nationally recruiting over 24,000 participants into NIHR portfolio studies. This is approximately over 30% of the total number of participants of research studies within our Research Delivery Network in South London. For the financial year 2022/23, the NIHR budget for the R&D Department totalled approximately £22.6m. We are the most active research partner in the King's Health Partners Clinical Trials Office for contract commercial clinical trials with over 60% of the commercial trials portfolio in 2024/25 lead by the Trust.
Job description
Job responsibilities
- Named as the Production Manager on the GMP units MHRA manufacturing authorisation.
- Develop, maintain and manage production schedules in line with the units budget.
- Design, deliver and provide relevant training courses to meet the needs of unit staff and users.
- Develop required manufacturing process for manufacturing campaigns and develop and maintain required documentation and specification files.
- Assist collaborators and users with Clinical Trial Authorisation submissions including the Investigational Medicinal Product Dossier. Conduct procurement in line with GMP requirements and the Trust processes.
- Along with the Head of Quality, ensure that the maintenance, operation, cleaning and validation of the Unit and equipment are completed in compliance with units stated procedures and standards, including obligations in the units Validation Master Plan and Planned Preventative Maintenance plan.
- Establish, implement and ensure adherence to the quality management system.
- Provide line management for key GMP Production staff and lead on recruitment, induction, appraisal, training and development and retention of production staff.
- Represent the Trust at national and international meetings, presenting the Unit and its work, so as to highlight the benefits of using the Unit to the ATMP sector
- Play a key role in developing new business of the unit and building a pipeline of income generating manufacturing campaigns.
Person Specification
Qualifications / Education
Essential
- Education to post graduate degree level in appropriate subject area - MSc or equivalent experience
Desirable
- PhD or equivalent qualification
Previous Experience
Essential
- Considerable experience of managing production, qualification, quality and documentation activities in a GMP environment.
- Proven experience of managing complex production schedules in a GMP environment and ensuring the implementation of operating procedures and efficient record keeping
- Extensive experience in a supervisory role. This includes the ability to lead, develop, motivate and manage a team of production scientists.
- Strong project management experience
- In depth understanding and experience of cell therapy processes (e.g. purification, culture, expansion and genetic modification using viral vectors regulatory T cells, ES Cells and other non-adherent cells).
- In depth understanding and experience of the following unit processes -MACS, FACS, bench scale centrifugation and density gradient centrifugation -Cell expansion in closed systems -Purification and formulation of ATMPs
- Experience of managing a budget
Desirable
- In depth understanding and experience of: -Tissue engineered products
- Dissolution, sterilisation by filtration and small scale manual aseptic filling In depth understanding and experience of small scale chromatography, small scale Micro and Ultrafiltration
- Experience of computerised Document Management systems such as Q-Pulse
- Support to the expansion and / or modification of existing GMP infrastructure
Skills, Knowledge and Ability
Essential
- In depth understanding of legislative framework of MHRA, HTA and H&SE in Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials.
- Knowledge of Good QC Laboratory Practice and routine in-process controls (IPC) and QC assay techniques such as flow cytometry, sterility testing, mycoplasma testing, ELISA, NAT/PCR assays
- Good communication skills both verbally and in written form. Experience of report writing for Board level staff and presentation skills.
- Strong organisational skills with a proven ability to manage competing demands.
- Commercially aware and able to manage procurement, and contracts
- Good computer skills
Desirable
- 20L disposable bioreactors, small scale chromatography, small scale Micro and Ultrafiltration, hand filling into vials
Additional Information
Essential
- Resilience and flexibility; able to contribute innovatively to solving process development problems.
- Well motivated with evidence of an ability to work without direct supervision and to use own initiative
- Ability to develop and maintain good working relationships with all levels of staff
- Highly professional approach to work, in particular in dealing with confidential information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Guy's and St Thomas' NHS Foundation Trust
Address
Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Employer's website
https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)