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Job requirements
Essential
18 listedRequirements the employer expects applicants to meet.
- Previous Experience
Considerable experience of managing production, qualification, quality and documentation activities in a GMP environment.
- Previous Experience
Proven experience of managing complex production schedules in a GMP environment and ensuring the implementation of operating procedures and efficient record keeping
- Previous Experience
Extensive experience in a supervisory role. This includes the ability to lead, develop, motivate and manage a team of production scientists.
- Previous Experience
Strong project management experience
- Previous 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).
- Previous Experience
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
- Previous Experience
Experience of managing a budget
- Additional Information
Resilience and flexibility; able to contribute innovatively to solving process development problems.
- Additional Information
Well motivated with evidence of an ability to work without direct supervision and to use own initiative
- Additional Information
Ability to develop and maintain good working relationships with all levels of staff
- Additional Information
Highly professional approach to work, in particular in dealing with confidential information
- Qualifications / Education
Education to post graduate degree level in appropriate subject area – MSc or equivalent experience
- Skills, Knowledge and Ability
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.
- Skills, Knowledge and Ability
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
- Skills, Knowledge and Ability
Good communication skills both verbally and in written form. Experience of report writing for Board level staff and presentation skills.
- Skills, Knowledge and Ability
Strong organisational skills with a proven ability to manage competing demands.
- Skills, Knowledge and Ability
Commercially aware and able to manage procurement, and contracts
- Skills, Knowledge and Ability
Good computer skills
Desirable
6 listedAdditional qualities the employer would prefer.
- Previous Experience
In depth understanding and experience of: - Tissue engineered products
- Previous Experience
Dissolution, sterilisation by filtration and small scale manual aseptic filling In depth understanding and experience of small scale chromatography, small scale Micro and Ultrafiltration
- Previous Experience
Experience of computerised Document Management systems such as Q-Pulse
- Previous Experience
Support to the expansion and / or modification of existing GMP infrastructure
- Qualifications / Education
PhD or equivalent qualification
- Skills, Knowledge and Ability
20L disposable bioreactors, small scale chromatography, small scale Micro and Ultrafiltration, hand filling into vials
Job overview
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.
Detailed job description and main 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 unit’s stated procedures and standards, including obligations in the unit’s 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.
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Applying for this NHS job
This advert is for Head of Advanced Therapies Production with Guy's and St Thomas' NHS Foundation Trust in London, England. It is listed as a Band 8 Head of service role. The advertised salary is £66,274 - £73,496 per annum. The contract type is Permanent. The application deadline is 03 Nov 2026.
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