Aseptic Services Manager for Clinical Trials Aseptic Services Unit

Aseptic Services Manager for Clinical Trials Aseptic Services Unit

Oxford University Hospitals NHS Foundation Trust is recruiting an Aseptic Services Manager to lead the day to day operation of the Clinical Trials Aseptic Services Unit (CTASU) at Churchill Hospital, Oxford. The role is a permanent, full time Band 7 contract with a pro rata salary of £47,810 - £54,710 per annum.

Job overview

The Manager will oversee aseptic preparation of medicines for clinical trials, ensuring compliance with GMP, QA and regulatory guidance. The position requires strong leadership, clinical trials expertise and a collaborative approach to continuous improvement and staff development.

Main duties

• Lead and manage the day to day service of CTASU, ensuring aseptic preparation of medicines runs in accordance with current guidance and best practice.
• Participate in identifying and implementing initiatives to reduce financial costs and environmental impact of CTASU service.
• Maintain comprehensive knowledge of national legislation, GCP, GMP and QA requirements for aseptic preparation and Good Manufacturing Practice.
• Support the Pharmaceutical Quality System (PQS), ensuring staff work according to the SOPs detailed in the PQS and that an ongoing validation programme demonstrates competency.
• Recruit, induct and manage staff, collaborate with the training team and ensure a competent workforce.
• Manage preventative maintenance and environmental monitoring programmes, review documentation and manage deviations to ensure compliance.
• Monitor and record internal and external incidents, taking corrective and preventive action as part of the Trust's Incident Monitoring Programme.
• Support NHS QA inspections, MHRA and sponsor audits, communicate complex regulatory information and manage findings.
• Participate in regional and national meetings and projects to support the advancement of Pharmacy Aseptic preparation and research.
• Ensure accurate financial records, invoicing and authorisation of invoices for payment.
• Ensure the CTASU and its staff operate to standards of excellence in customer care with a strong patient focus.

Person specification Qualifications

• Pharmacy Technician (SMT) Diploma
• Pharmacy Institute of the Pharmaceutical Society (PIPC) qualification
• Pharmacy Technician Quality Assurance (PTQA) or equivalent

Experience

• Experience in aseptic services
• Experience of training and supervision
• Knowledge of and ability to apply GMP and QA to aseptic services
• Experience of managing staff
• Experience working in Clinical Trials
• Experience working in Advanced Therapeutic Medicinal Products (ATMPs)

Personal skills

• Accurate work and attention to detail
• Capability of working under pressure
• Ability to liaise, explain and convey difficult information and messages to all staff and service users
• Teamworking and independent working ability

Behavioural

• Capable of working under pressure
• Ability to liaise, explain and convey difficult information and messages to all staff and service users
• Ability to work in a team and independently

Additional information

All meetings and interviews will be scheduled on Microsoft Teams from a verified OUH email account. If you have any doubts about correspondence around recruitment, please contact . The application will close automatically once the application limit is reached or the advertised closing date of 29 October 2025, 23:59 has passed.