Location
London

Hours
Full Time

Salary
£56,276 per annum

About the Role
As a Senior Production Scientist within the Advanced Therapies Manufacturing Unit, you will lead the manufacturing of immune cell therapy products to meet the clinical needs of participants on current and future clinical trials or Specials. You will assess the suitability of human cells received for manufacture, liaising with senior clinical staff when necessary, and ensure correct disposal of cells and patient samples in line with departmental and governmental policies. You will be responsible for labelling, documenting, and storing manufactured products according to authorised specifications and quality standards. Maintaining an up-to-date knowledge base of immunological products used in Adoptive Cellular Therapy is essential, alongside demonstrating advanced competencies through a personalised Continued Professional Development portfolio.

You will work independently and collaboratively with clinicians, scientists, and regulatory personnel, developing multicolour phenotyping panels for FACS profiles to enable cell selection and expansion. You will contribute to process development by transferring pre-clinical ideas into GMP-compliant manufacturing processes. Leading validation and qualification procedures for processes and equipment, you will provide specialist knowledge of the latest developments in cell and gene therapy manufacturing science and immunology.

Key responsibilities include developing and implementing controlled documents such as Investigational Medicinal Product Dossiers, Product Specification Files, Batch Manufacturing Records, and Standard Operating Procedures (SOPs) for GMP production activities. You will ensure maintenance and supervision of equipment, compliance with Planned Preventive Maintenance (PPM), and undertake strategic judgements within the Pharmaceutical Quality Systems (PQS). Proficiency in advanced scientific data analysis and familiarity with specialist software such as R, FlowJo, and GraphPad Prism is desirable.

The role requires hands-on experience in aseptic GMP manufacturing of Advanced Therapy Medicinal Products (ATMPs), excellent communication skills, and the ability to innovate and develop the service to maintain its world-leading status. You will also represent the Unit at meetings and seminars, plan and prioritise GMP equipment workload, manage production deviations, and provide supervision and training to production staff. When required, you may act as Deputy for the Production Manager.

Working conditions involve prolonged concentration, cleanroom work, and occasional moderate physical effort including sitting and standing for extended periods while operating specialist manufacturing equipment. High levels of dexterity, hand-eye coordination, and accuracy are essential. Exposure to distressing or emotional circumstances is rare but may occur.

Experience
- Proven experience in aseptic GMP manufacturing of immune cell or gene therapy products.
- Demonstrated ability to lead validation and qualification procedures.
- Experience working independently and as part of multidisciplinary teams.
- Proficiency in advanced scientific data analysis and familiarity with software such as R, FlowJo, and GraphPad Prism is desirable.
- Experience in developing and implementing GMP documentation and quality systems.

About you
- Highly motivated, detail-oriented, and able to work under prolonged concentration.
- Strong communication skills with the ability to work effectively with diverse stakeholders.
- Innovative and pragmatic problem solver with a can-do attitude.
- Able to provide professional supervision and training to junior staff.
- Flexible and adaptable to changing priorities and workloads.
- Commitment to maintaining up-to-date knowledge in immunology and cell therapy manufacturing.

Qualifications
- Relevant scientific degree or equivalent qualification in a related field.
- Continued Professional Development portfolio demonstrating advanced competencies.
- Knowledge of Pharmaceutical Quality Systems (PQS), GMP regulations, and risk assessment methodologies.
- Understanding of regulatory requirements for Clinical Trial Authorisation (CTA) submissions and data management.