Senior Production Scientist (Advanced Therapies Manufacturing)

The position on offer allows the applicant an opportunity to become involved in cutting edge translational research at the interface between science and clinical medicine and is a reflection of bench to bedside concept.
Working under the trusts Pharmaceutical Quality System, the post holder will use their experience and specialist knowledge in Good Manufacturing Practice (GMP), immune cell culture, immune cell purification by high end multicolour flow Cytometry and or other methods to take responsibility for developing and delivering the manufacturing process for novel cutting edge clinical trial studies. Also, a significant attribute of this job would be to supervise a team of production scientists., Senior Advanced Therapies Production Scientist, Advanced Therapy Manufacturing Platform -NIHR Guy's Hospital, + Lead and supervise production scientists in the batch manufacture of IMP/Specials under the centre's license
+ Lead and supervise staff in the validation of equipment's and processes as per local procedures
+ Lead as a scientific expert for technology transfer of new projects
+ Lead and supervise staff in process development/improvement activities
+ Ensure by working with the Head of Production that production of clinical trial products meet on time in full targets
+ Ensure with Head of Production planned maintenance work schedule is followed and suggest system improvements
+ Supervise Production Scientists and actively assist them with their workload
Therefore, this post requires someone with good attention to detail, a quick learner, flexible, able to work under changing landscapes and has strong communication skills with a positive can-do attitude., 4.1. Professional / Clinical Responsibilities

• Responsible for delivering a highly specialist clinical technical service by leading in the manufacturing of immune cell therapy products for the clinical needs of participants on current and future clinical trials or "Specials".


• Assess the suitability of human cells received for manufacture and liaise with senior clinical staff for action or advice if unsuitable.


• Ensure the correct disposal of cells and/or patient samples in accordance with relevant departmental and governmental policies.


• Ensure that manufactured products are labelled, documented and stored according to authorised specifications and quality standards.


• Responsible for maintaining an up-to-date knowledge-base of Immunological products used in Adoptive Cellular Therapy while demonstrating advanced competencies through a personalised Continued Professional Development portfolio.


• Capable of working independently and as part of a team of clinicians, scientists and regulatory personnel.


• Required to work with users of the BRC Advanced Therapies Manufacturing Unit to develop multicolour phenotyping panels for FACS profiles to allow cell selection and subsequent cell expansion.


• Required to work with collaborators in developing processes by taking pre-clinical ideas and technology transferring to the unit and ensuring phase appropriate GMP compliance


• Lead Validation and qualification procedures for processes and equipment's used for manufacture of immune cell products

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• Provide specialist knowledge of the latest developments within cell and gene therapy manufacturing science and technology


• Provide specialist knowledge of Immunology of human cells and suggesting continuous process improvement ideas


• Report result outcomes and provide specialist advice to clinicians, investigators and scientists in clinical development.


• Take responsibility for developing and implementing independently controlled documents: Investigational Medicinal Product Dossiers, Product Specification Files, Batch Manufacturing Records and Standard Operating Procedures (SOPs) for Production activities in the GMP unit.


• Ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM)


• Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS)


• Qualify, validate and re-validate equipment and GMP procedures successfully and on-schedule according to the Unit's Validation Master Plan (VMP) and PQS


• Hands-on experience operating in an aseptic GMP Unit manufacturing ATMPs will provide you with the skills to meet these developing needs.


• Be proficient in advanced scientific data analysis. Knowledge of specialist scientific software e.g. R, Flow Jo, Graphpad Prism is desirable


• Show advanced level knowledge of Immunology in the context of cell activation, growth , functionality and potency of immune cells

4.2 Management and Leadership Responsibilities

• Communicate with colleagues about specialist complex manufacturing procedures, you will bring innovation and development to the role, ensuring that the service provided by the Unit remains world-leading.


• Disseminate research and specialist technical knowledge. Attend and lead in presenting at BRC meetings, seminars and national or international meetings where deemed appropriate.


• Plan and prioritise the use of specialist GMP equipment workload, liaising with other departments, and suppliers in relation to manufacturing ATMPs.


• Interact with the Unit's capacity planning system to ensure the smooth running of the Unit.


• Work unsupervised managing production deviations, making informed decisions relating quality systems.


• Provide day-to-day professional supervision and practical training for production activities and ongoing supervision of support staff, and new and junior staff.


• When required /able to act as the Deputy for the Production Manager supervising Production staff members, and managing Production schedules.


• Good communications skills , being able to work with different stakeholders and their project specific needs

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• Can-do attitude, flexibility and pragmatic approaches to problem solving is required.

4.3 Quality Responsibilities

• Operate within the Pharmaceutical Quality System: Have an understanding of PQS tools such as Deviation/Change management additionally an understanding of risk assessments is required.


• Where directed or delegated by the Head of Advanced Therapy Quality, you will help develop specific, accurate, precise and robust specialist Quality Control assays to be used following immune cell therapy production.


• Assist in the management and monitoring of Quality Assurance and Quality Control activities, ensuring that agreed quality standards of service are maintained.

4.4 Documentation Responsibilities:
Using your specialist knowledge you will undertake the development and generation of:

• Unit-specific SOPs and policies relating to and manufacturing operations. These must comply with GMP and the Unit's manufacturing licence.


• Product-specific SOPs and batch-specific documentation for the manufacture of ATMPs.


• Product Specification Files or Preparation Process Dossiers and or IMPD's for cell therapies.

4.5 Information Management Responsibilities

• Play a major role in generating data for the application to the regulatory authorities for Clinical Trial Authorisation (CTA). You will record meticulously all data generated for the CTA submission to GMP standards.


• Work in compliance with national standards for the safe, secure and confidential processing and storage of patient and laboratory information and when accessing patient information on computer databases.


• You will be active interpreting data, and participate in writings for publication.

4.6 Working Conditions:
The role calls for a detail-orientated and highly-motivated individual with the ability develop ex-vivo immune cell culture protocols using specialist data analysis tools.

• Prolonged concentration is required when processing samples, and operating specialist manufacturing equipment. There will be prolonged work in a clean room.


• There will be occasional moderate physical effort requirement for sitting and standing in a restricted position for a substantial proportion of time working in Grade A Isolator systems. There will be sitting and standing daily for bench work for long periods, with frequent repetitive movements.


• You will need excellent highly developed physical skills where accuracy is important; hand-eye co-ordination and accuracy for processing material as well as excellent dexterity for the fine adjustments to specialist equipment.

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• Exposure to distressing or emotional circumstances is rare but may occur, with limited patient contact.

Guy's and St Thomas' celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study's at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.
Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.
Flexible working
We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual's personal circumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.
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Guy's and St Thomas' is among the UK's busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.
Guy's is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary's Hospital in Sidcup. St Thomas' has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children's Hospital.
Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions.
Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.
In February 2021 the Royal Brompton and Harefield joined Guy's and St Thomas' NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.
We have a reputation for clinical excellence and high quality teaching and research. We are part of King's Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King's College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.
Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of 'good'. Our adult community services achieved a rating of 'outstanding'.
The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients.
We have one of the most ambitious capital investment programmes anywhere in the NHS.