Job Description

An exceptional opportunity has arisen to provide leadership and quality sign off for the design, build and validation of a purpose built Paediatric Cancer and ATMP facility due to open at St Thomas' Hospital in September 2026 and once opened, to lead the core functions of the new unit and the existing Guy's Cancer centre chemotherapy and advanced therapy facility with overall responsibility for the services provided.Main duties of the job

• To provide technical leadership for all aspects of the chemotherapy (including clinical trials) and advanced therapies services being provided from the St Thomas and Guys Cancer Centre and Guy's Pharmacy Containment Suite.
• To lead, deliver, develop and evaluate a comprehensive aseptic service including adult and paediatric chemotherapy, advanced therapies and aseptic manufacturing services to the Trust in accordance with the objectives set between the Chief Pharmacist, ACP Technical services and Clinical Pharmacy Services Cancer, Paediatrics and ATMP leads.
• To be responsible for strategic development of aseptic services within and external to the Trust in line with regionally and nationally agreed NHS priorities
• To be responsible for the research and development program within aseptic services ensuring that projects are identified, delivered and documented within an agreed time frame in collaboration with the clinical trials teams.

About usJoin Us at the Forefront of Innovation in Cancer & Advanced Therapy Care!Pharmacy Aseptic Services - Guy's & St Thomas' NHS Foundation TrustWe're embarking on a groundbreaking journey--and we want you to be a part of it.Guy's & St Thomas' is building a brand-new, state-of-the-art Pharmacy Aseptic Unit at our St Thomas' site, purpose-built for the preparation of chemotherapy and cutting-edge advanced therapies. This is more than just a project--it's a transformation that will shape the future of patient care.Why Join Us?

• Be at the centre of innovation: Play a vital role in designing and launching a modern aseptic facility.
• Drive real impact: Your expertise will directly contribute to improving outcomes for patients requiring highly specialised treatments.
• Work with the best: Collaborate with leaders across pharmacy, clinical services, procurement, finance, and Trust management.Shape the future: Influence every stage--from specification and validation to full operational delivery--with quality and patient care at the heart of it all

What You'll Be Doing:

• Leading on technical aspects of the new unit's design and operation.
• Ensuring full compliance with regulatory and quality standards.
• Being a key voice in a cross-functional project team to create a facility that is future-ready.
• Helping to deliver a unit that reflects the evolving needs of modern medicine.

Date posted25 April 2025Pay schemeAgenda for changeBandBand 8cSalaryxc2xa382,462 to xc2xa393,773 a year per annum incl. HCAContractPermanentWorking patternFull-timeReference number196-SMT1717Job locationsSt Thomas HospitalWestminster Bridge RoadLondonSE1 7EHJob descriptionJob responsibilitiesPhase 1 Project Implementation

• To provide leadership and operational support to the technical project lead and deputise in their absence from a technical perspective.
• To prepare and / or approve all procedures, validation documents from a production perspective for submission or amendment upon return from QA lifecycle, general QA and the Technical Project Lead.
• To liaise closely with the Transformation Manager on all aspects of the project timeline to ensure all tasks are scheduled and completed within the expected timeline
• To select contractors to provide the facility ensuring functional specification compliance with the user requirement specifications.To support all procurement processes for the project including qualitative review of tenders.
• To prepare technical summary reports on project progress to be presented at the Phase 1 project meetings and the Aseptic Programme Board.
• To provide operational oversight of contractors for all validation activities required for facility commissioning: IOPQ execution, APS execution and PV activities.
• To review all executed validation and commissioning documentation from a production perspective prior to submission to QA / QA lifecycle.
• To write the facility start up plan for the Phase 1 facility and liaise with existing aseptic services to ensure full integration with other aseptic units
• To represent the facility at new unit inspection prior to facility opening and provide regular updates to Regional Quality Assurance on the project progress.
• To liaise with appropriate clinical teams in Cancer Services, Paediatrics and Advanced Therapies to ensure the facility is able to provide the expected service deliverance and maintain appropriate capacity for the service requirements.
• To prepare and own the facility capacity plan.
• To manage the new product introduction process including process validation.
• To prepare the development strategy to ensure a robust and fit for purpose manufacturing workforce.

Post Project: See details in job description Job descriptionJob responsibilitiesPhase 1 Project Implementation

• To provide leadership and operational support to the technical project lead and deputise in their absence from a technical perspective.
• To prepare and / or approve all procedures, validation documents from a production perspective for submission or amendment upon return from QA lifecycle, general QA and the Technical Project Lead.
• To liaise closely with the Transformation Manager on all aspects of the project timeline to ensure all tasks are scheduled and completed within the expected timeline
• To select contractors to provide the facility ensuring functional specification compliance with the user requirement specifications.To support all procurement processes for the project including qualitative review of tenders.
• To prepare technical summary reports on project progress to be presented at the Phase 1 project meetings and the Aseptic Programme Board.
• To provide operational oversight of contractors for all validation activities required for facility commissioning: IOPQ execution, APS execution and PV activities.
• To review all executed validation and commissioning documentation from a production perspective prior to submission to QA / QA lifecycle.
• To write the facility start up plan for the Phase 1 facility and liaise with existing aseptic services to ensure full integration with other aseptic units
• To represent the facility at new unit inspection prior to facility opening and provide regular updates to Regional Quality Assurance on the project progress.
• To liaise with appropriate clinical teams in Cancer Services, Paediatrics and Advanced Therapies to ensure the facility is able to provide the expected service deliverance and maintain appropriate capacity for the service requirements.
• To prepare and own the facility capacity plan.
• To manage the new product introduction process including process validation.
• To prepare the development strategy to ensure a robust and fit for purpose manufacturing workforce.

Post Project: See details in job descriptionPerson SpecificationQualificationsEssential

• Active professional registration without restrictions with the General Pharmaceutical Council
• Specialist higher degree (Masters) in technical services or quality assurance (e.g. National course in Pharmaceutical Technology & Quality Assurance MSc) or equivalent portfolio of experience

ExperienceEssential

• Successful management / leadership at a senior level of aseptic facilities
• Previous assessable experience of managing the introduction, operation and audit of clinical trials according to GMP and GCP
• Previous assessable experience of the design, building, commissioning and qualification of new aseptic facilities and equipment
• Previous assessable experience of developing and expanding technical services to meet specific patient needs and reducing patient risk

KnowledgeEssential

• Advanced knowledge of contamination control requirements within aseptic services and previous experience of developing a contamination control strategies
• Detailed current knowledge of: o EudraLex MHRA and QAAPs requirements, and the British and European pharmacopoeial requirements for raw materials, intermediates, and finished products. o Legislation relating to medicines e.g. HMR 2012/ 1916 o Advanced knowledge of isolators and laminar airflow technology
• Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products
• Knowledge of current best practice in the governance and aseptic preparation of AT(I)MPs

SkillsEssential

• Demonstrated ability to lead, inspire and motivate others to high performance by agreeing clear goals and objectives, providing support and guidance and creating opportunities for development
• Demonstrated ability to provide guidance to the manufacturing teams on solving any mal-functions or problems within the manufacturing facility and ensure outcomes are satisfactory
• Demonstrated ability to evaluate the effect changes in workload, staffing and service development (capacity planning) have on service delivery and to ensure that appropriate actions are applied to ensure that the services operate at low risk to patients at all times
• Demonstrated ability to identify, document, communicate, escalate and manage risks

Person SpecificationQualificationsEssential

• Active professional registration without restrictions with the General Pharmaceutical Council
• Specialist higher degree (Masters) in technical services or quality assurance (e.g. National course in Pharmaceutical Technology & Quality Assurance MSc) or equivalent portfolio of experience

ExperienceEssential

• Successful management / leadership at a senior level of aseptic facilities
• Previous assessable experience of managing the introduction, operation and audit of clinical trials according to GMP and GCP
• Previous assessable experience of the design, building, commissioning and qualification of new aseptic facilities and equipment
• Previous assessable experience of developing and expanding technical services to meet specific patient needs and reducing patient risk

KnowledgeEssential

• Advanced knowledge of contamination control requirements within aseptic services and previous experience of developing a contamination control strategies
• Detailed current knowledge of: o EudraLex MHRA and QAAPs requirements, and the British and European pharmacopoeial requirements for raw materials, intermediates, and finished products. o Legislation relating to medicines e.g. HMR 2012/ 1916 o Advanced knowledge of isolators and laminar airflow technology
• Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products
• Knowledge of current best practice in the governance and aseptic preparation of AT(I)MPs

SkillsEssential

• Demonstrated ability to lead, inspire and motivate others to high performance by agreeing clear goals and objectives, providing support and guidance and creating opportunities for development
• Demonstrated ability to provide guidance to the manufacturing teams on solving any mal-functions or problems within the manufacturing facility and ensure outcomes are satisfactory
• Demonstrated ability to evaluate the effect changes in workload, staffing and service development (capacity planning) have on service delivery and to ensure that appropriate actions are applied to ensure that the services operate at low risk to patients at all times
• Demonstrated ability to identify, document, communicate, escalate and manage risks

NHS