Aseptic Services Lead for Clinical Trial Injectables

The Christie NHS Foundation Trust; Manchester; On-site; GBP 34,000 - 43,000; Full time

Benefits offered by this job

Recruit and Retain payments of £2,000

Job summary

The Christie NHS Foundation Trust in Manchester is seeking an experienced professional to supervise and participate in aseptic production of clinical trial materials, SACT, EAMS and gene therapy products within a dedicated Aseptic Services Unit. The role emphasises team supervision, precise syringe handling and adherence to GMP in a state-of-the-art clean room environment.

You will oversee junior staff, co-ordinate daily workloads, ensure strict aseptic practices, and participate in on-call

Responsibilities

• Preparation of worksheets and labels for aseptically prepared products
• Setting up work trays for aseptically prepared products
• Sanitisation and transfer of all materials required for production
• Aseptic preparation of injectable materials
• Cleaning of facilities and isolators prior to and post production
• In process checks
• Supervision of junior staff
• Recording and maintaining the correct parameters to allow for aseptic manipulation within the isolators
• Checking of all components and consumables required for safe manipulation of aseptically prepared products
• Taking monitoring samples using TSA and SAB plates
• Plan, organise and prioritise work activities within clean rooms
• Ensure all processes and procedures are followed by staff operating in the ASU
• Responsible for the safe use of equipment within clean rooms
• Ensures that all required functional tests, inspections and verifications are carried out on clean room equipment
• Reports equipment faults and deviations and ensures deviations are authorised and records are diligently completed
• Delivering products and service as part of the Aseptic team
• To be part of the dispensing service for systemic anti-cancer therapy (SACT)
• To aseptically dispense products within aseptic facilities including measuring volumes and no-touch techniques
• To participate in aseptic unit cleaning rota and stock management
• To communicate effectively with healthcare professionals within and outside the Trust
• To carry out stock ordering through multiple supply channels and monitor stock levels
• Be able to participate in the on-call rotation for making 'out-of-hours' aseptic SACT
• To train junior members of staff in core areas
• Be available for potential move to seven day working
• Support and maintain the Quality Assurance system
• To participate in departmental audits and assist with SOP updates and validations
• Support the Chief Technicians and Highly Specialised Technicians
• To perform any other duties as requested by the line manager
• All duties to be performed in accordance with COSHH, GMP and regulatory requirements
• To ensure aseptic work is performed to high quality standards and patient safety is maintained

Job description

The Christie NHS Foundation Trust in Manchester is seeking an experienced professional to supervise and participate in aseptic production of clinical trial materials, SACT, EAMS and gene therapy products within a dedicated Aseptic Services Unit. The role emphasises team supervision, precise syringe handling and adherence to GMP in a state-of-the-art clean room environment.

You will oversee junior staff, co-ordinate daily workloads, ensure strict aseptic practices, and participate in on-call