Specialist Aseptic Services Pharmacist

Job overview

There has never been a more exciting and innovative time to work within aseptic services at The Christie NHS Foundation Trust. An excellent opportunity has become available for a person with interest in Aseptic Services.  You will be joining our dynamic aseptic team at an exciting and challenging time in developing a first-class aseptic service. The aseptic unit is unlicensed and provides an extensive portfolio of Clinical Trials, including Phase 1 and Gene therapy, alongside Early Access Medicines and compassionate use schemes. The unit is comprised of two cleanrooms, one dedicated to Gene therapy, with a total of five negative pressure isolators. You will work closely with other members of our multi-disciplinary teams to ensure that Christie patients have access to the very latest developments in oncology and haematology medicines. You will become an integral part of our aseptic service, clinical and research teams. The Pharmacy Department is also supporting several collaborative projects alongside several research partners and has strong links with the University of Manchester.  Several members of our staff have undertaken post graduate training, research and other secondment opportunities and we are keen to support more.

Main duties of the job

• To be involved in all aspects of the preparation of aseptically prepared medicines under section 10 of the Medicines Act 1968, including all clinical trial preparation.  •    To assist the Aseptic Services Manager in identifying, evaluating and developing new Aseptic services, analysing data, evaluating need, assessing local and national initiatives.  •    To act as the Accountable Pharmacist in Aseptic Services in the absence of the Aseptic Services Manager, taking responsibility for the preparation of medicines under section 10 of the Medicines Act 1968. •    Along with the Aseptic Services Manager, to take a lead role in planning, designing, negotiating, commissioning and operating new aseptic facilities or upgrades to existing facilities.  •    Along with the Aseptic Services Manager, be involved in ensuring all staff are trained and adequately assessed through effective training programmes in line with local regional and national guidance.  •    To maintain safe and effective aseptic services, evaluating and prioritising services when constraints occur and liaising and negotiating with managers and clinicians within pharmacy and externally when these constraints occur.  •    To assist the Aseptic Services Manager in maintaining and developing the Quality System.  •    To support the provision of research by the Aseptic Services Department.

Detailed job description and main responsibilities

Service Development •    Contribute specialist pharmaceutical expertise to the evaluation of new products, equipment, devices, and clinical trial processes, to inform safe and effective service development within the Aseptic Services Unit. •    Analyse and interpret service requirements for new methods of work, to support continuous improvement and innovation in aseptic services delivery. •    Develop and maintain the Quality Management System, to ensure compliance with regulatory standards and continuous quality improvement.

Aseptic Services •    Prepare aseptic medicines in accordance with approved procedures, to ensure products are safe, accurate, and fit for clinical use. •    Undertake aseptic verification checks at defined stages, to maintain accuracy and product quality throughout preparation. •    Supervise aseptic unit staff and review completed work, to ensure compliance with Standard Operating Procedures and quality standards. •    Deliver a high-quality aseptic dispensing service, to meet agreed standards for timeliness, safety, and patient care. •    Perform and validate complex dose calculations, to ensure accurate dosing of high-risk medicines. •    Check and approve aseptic products as an authorised checker, to ensure all products meet required specifications prior to release. •    Enforce adherence to cleanroom hygiene and gowning procedures, to maintain environmental control and minimise contamination risk. •    Complete and review operational documentation, to ensure accurate records and traceability of aseptic processes. •    Apply knowledge of clinical developments in patient care, to support safe and relevant aseptic service provision. •    Prepare and release intrathecal chemotherapy (once accredited), to ensure safe supply of high-risk treatments. •    Monitor and optimise use of departmental resources, including contracts, to ensure cost-effective service delivery. •    Identify, procure, and manage aseptic equipment and consumables, to maintain uninterrupted service provision within budget constraints. •    Manage stock levels within aseptic services, to ensure availability of critical medicines and materials. •    Ensure compliance with legislation governing medicines handling, to uphold legal, professional, and safety standards. •    Monitor and reduce SACT waste, to improve efficiency and environmental performance. •    Develop and validate aseptic-related digital systems, to ensure systems are safe, effective, and fit for purpose. •    Supervise Section 10 aseptic preparation activities, to ensure compliance with national guidance and product fitness for use. •    Provide expert advice to multidisciplinary staff, to support safe and effective aseptic practice. •    Coordinate daily aseptic workload with senior technical staff, to prioritise patient care and optimise unit capacity. •    Ensure all production activities follow GMP and SOPs, to maintain regulatory compliance and product quality. •    Support validation of electronic worksheet systems, to ensure accuracy and reliability of digital processes. •    Contribute to service and product development initiatives, to enhance aseptic services delivery. •    Support strategic planning with senior aseptic leadership, to guide long-term service development. •    Support audit activity and Quality Management System processes, to ensure ongoing regulatory compliance. •    Contribute to business case development and implementation, to support service expansion or infrastructure improvement. •    Develop and review COSHH and stability documentation, to ensure safe handling of hazardous substances and product integrity. •    Ensure compliance with national directives and clinical trial regulations, to support safe and lawful service operation. •    Act as a professional role model and mentor, to support staff development and maintain high professional standards. •    Participate in practice research activities, to support evidence-based service improvement.

Policy •    Develop and review aseptic policies and procedures, to ensure alignment with legislation, guidance, and best practice. •    Promote adherence to Trust and departmental policies, to ensure safe and consistent working practices. •    Maintain patient and service confidentiality, to comply with legal and professional requirements.

Clinical Governance •    Maintain Quality Assurance standards, to ensure compliance with local, regional, and national requirements. •    Undertake audit activities and produce reports, to monitor performance and drive service improvements. •    Coordinate annual validation activities, to ensure environmental and process compliance. •    Promote adherence to policies and procedures within the ASU, to ensure safe, efficient, patient-centred care. •    Record and manage quality incidents and deviations, to ensure timely resolution and continuous improvement. •    Monitor errors and incidents and implement CAPAs, to reduce risk and enhance patient safety. •    Participate in departmental governance meetings, to support service development and compliance with statutory guidance. •    Apply and authorise change control processes, to ensure safe implementation of new or revised systems and products. •    Support investigation of out-of-specification results and deviations, to maintain product quality and compliance. •    Manage complaints effectively, to achieve timely resolution and maintain service standards.

Education and Training •    Maintain and develop specialist knowledge in aseptic services and quality assurance, to support safe and effective practice. •    Keep up to date with professional and policy developments, to ensure practice remains current and compliant. •    Deliver and support staff training and competency assessments, to ensure all staff meet required standards. •    Develop and coordinate structured training programmes, to build workforce capability within aseptic services. •    Support the training and supervision of rotational pharmacists, to ensure effective learning and service delivery. •    Engage in and promote continuing professional development (CPD), to maintain professional registration and competence. •    Lead competency-based aseptic training programmes, to ensure safe and consistent practice. •    Develop expertise in aseptic services and staff development, to support continuous improvement of the service and workforce.