Advanced Therapy Medicinal Products (ATMP) Lead Aseptic Technician

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 appropriateaccreditation. 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 areescalated. 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 competencyframeworks 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 ContinuousProfessional 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 trials 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 patientsafety. 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 Trusts 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 accordingto 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