Lead Pharmacy Technician – Aseptic Clinical Trials and Production

Job overview

Full time: 37.5 hours per week fixed term to cover maternity leave

We are looking for a Lead Pharmacy Technician  to join our Aseptic Clinical Trials and Production. This is an excellent opportunity for an experienced technician with a background in Aseptic Services and Clinical Trials. The successful applicant will be working within an aseptic unit offering a high quality service.  You will be a key member of both Aseptic Services and Clinical Trials teams.

The suitable applicant should be highly motivated and show accurate attention to detail.  You should be organised and able to prioritise work effectively showing excellent interpersonal and communication skills.  There is a considerable commitment to clinical trials within this role and therefore great enthusiasm for research and development of new treatments is essential.

Main duties of the job

This role is the Aseptic Unit’s lead post for the management of the preparation of Investigational Medicinal Products (IMP) for patients who are subjects within clinical trials.  The role is an important link between Pharmacy and Research and Development with respect to aseptic product and is responsible for all GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice) aspects related to the preparation of sterile IMP

Detailed job description and main responsibilities

Lead responsibility for the management of the preparation of aseptically prepared Investigational Medicinal Products

• Responsible for the effective introduction and management of aseptically prepared clinical trial products, ensuring that the preparation of aseptic product for clinical trial is limited to reconstitution activities. •    Manage clinical trial material in the Aseptic Unit (including ordering, receipt, storage and documentation). •    Responsible for the maintenance of all procedures that relate to the reconstitution of Investigational Medicinal Products and comparators. •    Establishment of GMP instructional documents that will act as source information for staff in the Aseptic Unit for each Clinical Trial Project. •    Establishment of product specific documents (source information and production work sheets) for use in the Aseptic Unit for each Clinical Trial Project. •    Conduct final check of aseptic products on behalf of the Head of Production (prior to QA release to wards and customers). •    Support investigations related to events in production, particularly those that have involved clinical trial material. •    Responsible for the direct line management of pharmacy technicians and assistants.
• Responsible for the co-ordination and prioritisation of the Aseptic Unit workload. •    The job role will be split as approximately 0.6WTE undertaking clinical trial responsibilities and 0.4WTE undertaking production responsibilities. •    Perform duties in accordance with departmental procedures, GMP and hospital policy.