Job summary
The successful candidate will participate in and supervise the aseptic production of clinical trial, SACT, EAMS, FOC and gene therapy injectable medicines, and will oversee the daily work of aseptic staff during production. If you are interested in the safe manufacture of injectable medicines and would like to develop supervisory skills to support team management, this could be the ideal role for you.The Aseptic Services Unit at The Christie NHS Foundation Trust is a world leader in phase I clinical trial material, supporting over 100 trials as well as EAMS, FOC and compassionate use schemes. The ideal candidate will have strong concentration skills, the ability to accurately manipulate syringes and needles, and the capability to read syringe volumes precisely.The role requires the ability to stretch and twist when cleaning facilities and isolators. All work is performed within a clean room environment under the supervision of the Accountable Pharmacist and a highly trained technical team.This role is eligible for Recruit and Retain payments of £2,000 per annum while the scheme remains in place.
Main duties of the job
o Preparation of worksheets and labels for aseptically prepared products
o Setting up work trays for aseptically prepared products
o Sanitisation and transfer of all materials required for production
o Aseptic preparation of injectable materials
o Cleaning of facilities and isolators prior to and post production
o In process checks
o Supervision of junior staff
o Recording and maintaining the correct parameters to allow for aseptic manipulation within the isolators
o Checking of all components and consumables required for safe manipulation of aseptically prepared products (when suitably trained and qualified)
o Taking monitoring samples using TSA and SAB contact and settle plates
About us
We are an ever-expanding multi-disciplinary team of Assistants, Practitioners, Technicians, and pharmacists who strive to produce exceptionally high-quality injectable medicines to each patient that uses our service. The Aseptic team is a diverse and dynamic team who work in a specialised cleanroom environment where teamwork is the key to efficiency and managing the patient experience. Each day is both challenging and rewarding in equal measures, with cancer treatments constantly evolving and new types of drugs being trialled each year. We are at the forefront of developments in terms of drug innovation and team development, we were one of the first hospitals in the country to introduce the progression role of Aseptic Practitioner to pharmacy and we are looking forward within the next year to being able to add the Science Manufacturing Technician qualification to our already large portfolio of training and staff qualifications here at The Christie. We have recently developed a career pathway for technical staff wishing to progress from band 2 up to band 8a and support all qualifications and in house developments that allow for this progression should you wish to further your career within the pharmacy aseptic team. So, if you want to work as part of an ever-progressing team and you enjoy a challenge then we could be the team for you.
Job description
Job responsibilities
Supervision of cleanroom staff and workflow.
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, ensuring clean room staff use equipment in accordance with instructions and SOPs. Ensures that all required functional tests, inspections and verifications are carried out on clean room equipment before and after work sessions. Reports equipment faults and deviations and ensures that deviations are authorised and records are diligently completed.
Delivering products and service as part of the Aseptic team
Experience and knowledge in good manufacturing and processing procedures. To be part of the dispensing service for systemic anti-cancer therapy (SACT) requiring aseptic preparation including cytotoxic drugs, gene therapy and monoclonal antibodies from point of prescription receipt. To be aware and follow all departmental operating procedures and Good Manufacturing Practice (GMP) guidance at all times. To aseptically dispense products within the aseptic facilities including accurately measuring volumes and following aseptic no-touch techniques. To be responsible for the transfer disinfection into the aseptic units of all items required for aseptic processing, following departmental processes. To be fully aware of the COSHH regulations particularly with regard to the safe storage and handling of pharmaceutical products, to be aware of the Aseptic Spillage procedure and what to do in the event of spillage of a drug product. Carry out environmental monitoring with swabs, contact and settle agar plates. To be responsible for sending environmental monitoring samples to Quality Control in a timely manner. Provide support to the aseptic administration systems. To participate in aseptic unit cleaning rota, including cleaning of the aseptic units before and after core hours, if required. To undertake regular cleaning duties carried out during the working day. To set up and assemble work trays according to departmental SOPs in a timely and efficient manner. To carry out accuracy checks on assembled work trays, once trained following departmental programme and or PIPC certification. To co-ordinate daily workload, managing breaks and highlighting issues of productivity slowing down to a senior technician. To ensure adequate knowledge and understanding of clinical trials products prepared in aseptics relevant to the job role including accountability, stock control and storage requirements. To follow Good Clinical Practice (GCP) guidance and undertake where relevant data collection for aseptic clinical trial products. To communicate effectively with healthcare professionals both within and outside the Trust. To ensure good team working with other pharmacy staff, ward staff and other service providers as necessary. To carry out stock management including receipt, correct storage, stock count, expiry check and weekly ordering of all aseptic items including drugs, diluents and consumables. To carry out stock ordering through multiple supply channels and monitor stock levels. To be able to participate in the on-call rotation for making out-of-hours aseptic SACT if the service demands. To train junior members of staff in core areas as deemed appropriate by the Education & Training Lead. To contribute to bank holiday working where required. Be available and flexible to potential move to seven day working.
Support and maintain the Quality Assurance system.
To be aware of and participate, where required, in departmental audits. To assist in the updating and reviewing of SOPs and the building of drugs in the pharmacy computer system. To assist with annual and ad-hoc validations. Support and assist the Chief Technicians and Highly Specialised Technicians.
Other.
To perform any other duties as requested by the line manager, Aseptic Services Manager or Director of Pharmacy.
Person Specification
Qualifications
Essential
- NVQ Level 2 in Pharmacy Services or equivalent/higher nationally recognised qualification with willingness to complete Aseptic Pharmaceuticals Science Manufacturing Technician Level 3.
Desirable
- NVQ Level 3/BTEC in Pharmacy Services or equivalent nationally recognised qualification.
- Aseptic Pharmaceuticals Science Manufacturing Technician Level 3.
Experience
Essential
- Industrial/pharmaceutical or medical work-related background with specific knowledge of GMP/lab-based work experience.
Desirable
- Knowledge of GMP, clinical trials and hospital aseptic services.
Skills
Essential
- Proven skills in organising, supervising and training staff.
- Ability to make adjustments to workflow when the need arises.
- Ability to communicate to staff to extract maximum output with tact and diplomacy.
Knowledge
Essential
- Knowledge and the application of Standard Operating Procedures and Quality Assurance systems.
- Good manufacturing, dispensing or distribution practices.
- Knowledge of COSHH.
Desirable
- Attendance of Quality Assurance training programs.
Values
Essential
- Professional.
- Able to work under pressure.
- Extremely flexible and reliable.
- Ability to demonstrate the organisational values and behaviours.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
