Hi my name is Luke Chidgey and as the Aseptic Unit Manager, I am looking to recruit to the B6 Deputy Aseptic Unit Manager role, with a focus on ATMPs. In this exciting role, the main responsibilities are to be the Lead Aseptic Technician for Advanced Therapy Medicinal Products (ATMPs).
Working closely with the Accountable Pharmacist, Deputy Accountable Pharmacist and Aseptic Services Manager, you would be responsible for the co-ordination of ATMP injectable medicines to all relevant divisions within the Trust, ensuring compliance with technical, professional, best practice and regulatory guidance for the preparation and supply of ATMP. You would be part of a specialist aseptic team dedicated to aseptic dispensing of research medicines for patients in clinical trials.
The postholder will support the management, performance, and development of the ATMP unit as part of Clinical Trials Aseptic Services (CTAS), which provides injectable Investigational Medicinal Products and selected high risk injectable medicines to all divisions within the Trust. The ATMP unit will be used to aseptically dispense individual patient doses of ATMPs (licensed) or Advanced Therapy Investigational Medicinal products (ATIMPs).
To lead and manage the day-to-day service provided by ATMP unit and ensure that aseptic preparation of ATMP doses is carried out in accordance with current guidance.
To provide cost-effective delivery of high-quality aseptic pharmaceuticals that are prepared in a safe and efficient manner according to local standard operating procedures (SOPs).
To have a good working knowledge of relevant legislation, standards and guidance relating to the provision of ATMPs, aseptic services and clinical trials
To facilitate regional QA audits, internal QA self-inspections and sponsor audits, and to address any findings in a timely manner.
To work with the Aseptic Services Manager (ASM), Accountable Pharmacist (AP) and Deputy to maintain the Pharmaceutical Quality System (PQS).
Alongside the ASM and AP, to ensure all staff that work in ATMP unit are trained and competent to perform daily tasks, and that there is an ongoing validation programme in place to demonstrate ongoing competency.
To ensure the planned preventative maintenance and environmental monitoring programme is undertaken to ensure compliance with the standards.
To monitor and record all errors/near misses, taking corrective and preventative action if necessary, as part of the PQS and Trust’s Incident Monitoring Programme.
To ensure CTAS and its staff operate to standards of excellence in customer care and with a strong patient focus.
Full details are available in the attached job description.
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. For more information on OUH please view OUH At a Glance by OUHospitals - Issuu
Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community.
We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.
These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel .
Technical role
To maintain personal expertise, skills, and necessary knowledge of the technical aspects of aseptic dispensing.
To provide specialist technical advice to service users as necessary e.g., suitability of diluents, volume of diluents, administration routes and stability data.
To partake in the weekly rota where required, and perform specific tasks related to the preparation of an ATMP product such as completion of product worksheets, assembly of medicines and consumables, aseptic dispensing, packing prepared medicines for transport.
To perform pre and in-process checks of aseptically prepared products having undergone the appropriate
accreditation.
To ensure all medicines and consumables are stored appropriately.
To ensure finished products are transported appropriately according to any physical and regulatory
requirements including ATMPs e.g. Class 1 and 2 GMOs.
To ensure clean room and isolator cleaning standards, and to participate in the clean room/isolator cleaning rota as required, including additional requirements depending upon the ATMP type.
To ensure that daily, and other interval environmental monitoring is undertaken, assesses the results and in conjunction with Aseptic Unit Manager and Accountable Pharmacist implements actions.
To ensure that ATMP waste is managed and disposed of in accordance with OUH procedures and HSE guidance, including if needed local de-naturing.
To be responsible for ensuring that expiry date and stock level checks are carried out.
To ensure maintenance of departmental records including staff training, environmental monitoring, cleaning, maintenance logs and worksheets.
To ensure that planned preventative maintenance (PPM) is undertaken according to SOPs, and any issues are
escalated.
To support managing corrective & preventative actions.
To work collaboratively with the sponsors of the ATMP studies and OUH procurement team to oversee purchasing and distribution for the ATMP.
To liaise with external and internal suppliers of stock, consumables, equipment etc.
To be the named individual for the receipt of ATMPs.
To identify and monitor the needs of service users for ATMP unit and effectively plan and implement changes and improvements to the ATMP unit.
To support the development and commissioning of new equipment, processes or facilities through agreed SOPs and Change Control procedures.
To support the writing of SOPs and local controlled documents for pharmacy dispensing of ATMP.
Management
To be responsible for the supervision and day to day management of staff within CTAS and the ATMP unit.
To line manage technical CTAS staff and undertake annual appraisal.
To ensure all staff in the CTAS are appraised at least annually in line with OUH policy, and personal development plan and participate in Continuous Professional Development, including competency frameworks as appropriate.
To ensure staff maintain statutory and mandatory training to meet Trust requirements.
To work with the Lead Pharmacist for Education and Training and other senior staff to ensure individual training and educational needs of staff are identified and met through a programme of Continuous Professional Development, including the use of competency frameworks where appropriate.
Clinical Trials
To ensure pharmacy staff involved with the preparation and release of ATMP doses (ATMP staff) are compliant with relevant standards for the operation and management of Clinical Trials, including ICH-GCP and GMP.
To ensure the ATMP staff have appropriate ICH-GCP, GMP and ATMP training.
To work within the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 and EU directive relating to Clinical Trials.
To ensure compliance with clinical trial protocols and regulations regarding investigational medicinal products (IMPs) and clinical trial supplies.
To communicate with Investigators, Research Nurses, Trust R&D, Sponsors, Clinical Research Associates and Pharmacy staff during the set-up and running of a clinical trial.
To oversee the production, implementation and review of detailed written pharmacy guidance and SOPs for each clinical trial in accordance regulatory standards and each trial’s protocol.
To ensure clinical trial protocols are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol.
To maintain clinical trial filing systems and drug accountability documentation for clinical trials.
To support the training of medical, nursing and pharmacy staff in all aspects of handling drugs in clinical trials.
To liaise with other centres for clinical research to ensure common standards of practice.
To assist in the development of Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances.
Quality and Risk Management
To coordinate the management of QMS documentation (Change Controls, Deviations, Investigations, CAPA, Risk Assessments) and ensure proper recording and investigation of errors, incidents, and complaints.
To coordinate the management & updating of SOPs, Logs and controlled documents.
To conduct routine risk assessments on outsourced aseptic products and unlicensed medicines before approval for purchase.
To coordinate with OxPQAs and the Aseptic Services Manager to execute VMP actions and internal competencies, to ensure continued compliance with standards.
To support and manage the development and commissioning of new equipment and software, processes or facilities through agreed SOPs and Change Control procedures.
Teaching and Training
To be an accredited Pre and In Process Checker.
To support in the planning, writing and delivery of training programs for staff in CTAS involved with ATMP doses.
To support the Pre and In Process checking programme for technical staff in the CTAS, in liaison with the Aseptic Unit Manager and Pharmacy Education and Training Team.
To co-ordinate the training for rotational staff such as the Pharmacy Clinical Trial or Pharmacy Cancer teams involved with ATMP doses.
To work with the technician training team to ensure all ATMP staff are released for mandatory training and contribute as required to training and competency assessment of pharmacy staff as required.
To support and conduct ongoing competency/validation checks.
General responsibilities and Professionalism
To hold membership of a professional body and to undertake and maintain CPD as required.
To lead by example, maintaining high professional standards, and fostering a culture of quality and patient
safety.
To ensure confidentiality is maintained at all times.
To use experience and clinical judgment to assist in problem solving and troubleshooting.
To be professionally accountable for actions and advice.
To collect evidence to deal with complaints in accordance with the Trust’s complaints policy.
To be first point of contact for operational issues, queries, and concerns.
To participate in weekday service starting at 07:00, weekend, evening, and bank holiday working according
to rota.
Any other reasonable duties as requested by the Accountable Pharmacist, Associate Director of Pharmacy Clinical Trials, Research and Manufacturing, Clinical Director of Pharmacy and Sterile Services or line manager.
Liaises with:
Pharmacy Clinical Trials Team
Pharmacy Operational Managers for all sites
Clinical Pharmacists
Clinical Staff
Dispensary staff
Estates and Portering Managers
Clinical Research Associates
Principal Investigators and Researchers
Research and Development (R&D) staff
OUH Procurement
R&D Finance Personnel
CRUK & Research Network personnel
Quality assurance and quality control personnel
External suppliers & contractors e.g. PPM
