Job summary 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 inAseptic 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 licensed and provides an extensive portfolio of Clinical Trials, including Phase 1 and Gene therapy, along with 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 becomean integral part of our aseptic service, clinical and research teams. The Pharmacy Department is also supporting a number of collaborative projects alongside several research partners and has strong linkswith 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. Have a look at this short video which outlines what it's like to work at The Christiehttps://www.youtube.com/watch?vxuTC_PsYI8g&ab_channelTheChristieNHSFoundationTrust Main duties of the job To be involved in all aspects of the preparation of aseptically prepared medicines under Part 10 exemption of the Human Medicines Regulations 2012, including all clinical trial preparation. To assist the Aseptic Services Manager, and their deputy, 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, and their deputy in maintaining and developing the Quality System. To support the provision of research by the Aseptic Services Department. 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 roles 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 NHS Foundation Trust. The Pharmacy department has a developed career pathway for aseptic staff wishing to progress as far as achievable. Helping support all qualifications and in-house training 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. Date posted 20 January 2025 Pay scheme Agenda for change Band Band 7 Salary £46,148 to £52,809 a year per annum Contract Permanent Working pattern Full-time Reference number 413-89563-CSSS-LS-A Job locations Pharmacy Aseptics - E00921 Manchester M20 4BX Job description Job responsibilities Service Development To be involved in the contribution of specialist knowledge into the research and evaluation of new products, equipment, devices and methods of work, including clinical trials, analysing and interpreting the requirements for service developments within the Aseptic Services Unit. To be involved in the maintenance and development of the Quality Syste Aseptic To be competent in the aseptic preparation of medicines. To be involved in the Aseptic Verification process. To supervise staff working in the ASU and to check the work in accordance with ASU procedures. To be involved in ensuring the highest level of professional standards of service are provided from the Trust Aseptic Services Unit encompassing both quality and timeliness of service to patients and staff. To perform, and instruct others to perform, complex dose calculations. To act as a checker/product approver within Aseptic Services, checking the work of others members of staff in accordance with departmental procedures, throughout aseptic processing. To help to ensure that all staff adhere to hygiene and clothing policies associated with their work within the controlled cleanroom environment. This involves strict hand washing procedures and changing into designated cleanroom clothing. To help to ensure all documentation relating to the day to day operation of the ASU is completed correctly and reviewed at regular intervals. To understand the key developments around the provision of patient care. To be trained and registered to issue intrathecal doses. To help to ensure cost effective use of resources within Aseptic Services to include the review and monitoring of the cleanroom clothing and cleaning / decontamination solution contracts To be involved in identifying required equipment and resources and manage the cost effective purchasing of aseptic services equipment, consumables and resources. To be involved in the management of aseptic services stock ensuring stock levels. To comply with legal and other requirements related to the purchase, supply, use, safe custody and destruction of medicines within pharmacy and other areas of the Trust. To be involved in the monitoring of SACT waste and its reduction. To be involved in the development and management of software systems ensuring they are risk assessed and validated. Supervise the preparation of medicinal products made under section 10 of the medicines act 1968 and ensure compliance with Quality Assurance of Aseptic Preparation Services to provide products that are fit for their intended use. Act as an advisor to all staff if support or intervention is required. To coordinate with the senior technicians, the daily workload of medicines for injection to the wards and departments taking into account clinical priority, financial expediency and the capacity plan for the unit. Ensure all production operations are carried out according to pre-established Standard Operating procedures and in accordance with Good Manufacturing Practice. Responsible for the validation of the new pharmacy electronic worksheet system, in conjunction with the Aseptic Services Manager and their deputy. Contribute to the development of products and services, with the Aseptic Services Manager and their deputy. Liaise with the Aseptic Services Manager and their deputy for long term strategic development of Aseptic Services. Assist with the support and running of the Pharmacy Quality Management System (QMS), internal and external audits. Contribute to work on a business case for a new / significant refurbishment of the aseptic unit, and implementation of the resultant plans. To be involved is the compilation and review of COSHH documents in line with any changes, and compliant with COSHH (1988) Regulations. To be involved is the compilation and review of Stability documents in line with any changes. Assist in ensuring the unit is fully compliant with the requirements of the executive letter EL(97)52 issued by the department of health. Assist in ensuring the department is fully compliant with the requirements associated with the regulation of clinical trials. Assist the Aseptic Services Manager, their deputy and senior Technicians by acting as a role model and mentor. To contribute to and participate in practise research initiatives within the department. Policy To be involved in the compilation and review of Aseptic Services procedures in line with any changes in legal and ethical policy, Trust developments and local and regional guidance as well as departmental working arrangements. To be involved in ensuring the adherence and upholding of Trust and departmental policies and procedures by the Aseptic Services staff. To ensure confidentiality is maintained at all times. Clinical Governance To ensure that Quality Assurance standards are maintained in accordance with national, regional and local requirements. To assist the Aseptic Services Manager and their deputy in assigned audit activities and produce written reports and statistical information with identified action. To be involved, along with the Aseptic Services Manager and their deputy, in ensuring that the annual validation activities are carried out. To help to ensure staff within the ASU work within the policies and procedures in order to provide a safe, efficient, patient centred aseptic service. To help to ensure that all quality exceptions are documented and appropriate action is taken to resolve any issues raised. To assist the Aseptic Services Manager and their deputy to maintain systems which monitor, evaluate and report aseptic service errors and incidents and implement effective CAPAs. To be involved in ensuring the aseptic services support the developments of other pharmacy services and comply with relevant statutory and ethical guidance by taking an active role in departmental meetings. Ensure appropriate change control processes are followed and authorise changes to any existing product/process or the implementation of any new product or process. Assist the Aseptic Management Team with the management of out of specifications and product/process deviations relating to Aseptic Services. Ensure that any complaints are dealt with promptly and effectively to the satisfaction of both parties and that necessary documentation is completed. Education and Training To maintain and develop specialist knowledge of Aseptic Services and Quality Assurance, attending relevant training. Maintain specialist knowledge with relevant professional and policy developments relating to aseptic services. To be involved in ensuring that all Aseptic Services staff, including bank and locum staff while working in the ASU, are trained and validated and annual assessments are carried out. To be involved in developing and maintaining training programmes and competency assessments of Aseptic Services staff, including rotational pharmacists; organising and coordinating the work of rotational pharmacists within Aseptic Services. To undertake, and encourage others to undertake, continual professional development (CPD) in order to continually update pharmaceutical knowledge and to maintain inclusion on the Pharmacy Register. To be involved in ensuring the competency based aseptic services training of all aseptic staff. To develop and maintain an expertise and knowledge in issues related to aseptic services and the training and development of staff. Job description Job responsibilities Service Development To be involved in the contribution of specialist knowledge into the research and evaluation of new products, equipment, devices and methods of work, including clinical trials, analysing and interpreting the requirements for service developments within the Aseptic Services Unit. To be involved in the maintenance and development of the Quality Syste Aseptic To be competent in the aseptic preparation of medicines. To be involved in the Aseptic Verification process. To supervise staff working in the ASU and to check the work in accordance with ASU procedures. To be involved in ensuring the highest level of professional standards of service are provided from the Trust Aseptic Services Unit encompassing both quality and timeliness of service to patients and staff. To perform, and instruct others to perform, complex dose calculations. To act as a checker/product approver within Aseptic Services, checking the work of others members of staff in accordance with departmental procedures, throughout aseptic processing. To help to ensure that all staff adhere to hygiene and clothing policies associated with their work within the controlled cleanroom environment. This involves strict hand washing procedures and changing into designated cleanroom clothing. To help to ensure all documentation relating to the day to day operation of the ASU is completed correctly and reviewed at regular intervals. To understand the key developments around the provision of patient care. To be trained and registered to issue intrathecal doses. To help to ensure cost effective use of resources within Aseptic Services to include the review and monitoring of the cleanroom clothing and cleaning / decontamination solution contracts To be involved in identifying required equipment and resources and manage the cost effective purchasing of aseptic services equipment, consumables and resources. To be involved in the management of aseptic services stock ensuring stock levels. To comply with legal and other requirements related to the purchase, supply, use, safe custody and destruction of medicines within pharmacy and other areas of the Trust. To be involved in the monitoring of SACT waste and its reduction. To be involved in the development and management of software systems ensuring they are risk assessed and validated. Supervise the preparation of medicinal products made under section 10 of the medicines act 1968 and ensure compliance with Quality Assurance of Aseptic Preparation Services to provide products that are fit for their intended use. Act as an advisor to all staff if support or intervention is required. To coordinate with the senior technicians, the daily workload of medicines for injection to the wards and departments taking into account clinical priority, financial expediency and the capacity plan for the unit. Ensure all production operations are carried out according to pre-established Standard Operating procedures and in accordance with Good Manufacturing Practice. Responsible for the validation of the new pharmacy electronic worksheet system, in conjunction with the Aseptic Services Manager and their deputy. Contribute to the development of products and services, with the Aseptic Services Manager and their deputy. Liaise with the Aseptic Services Manager and their deputy for long term strategic development of Aseptic Services. Assist with the support and running of the Pharmacy Quality Management System (QMS), internal and external audits. Contribute to work on a business case for a new / significant refurbishment of the aseptic unit, and implementation of the resultant plans. To be involved is the compilation and review of COSHH documents in line with any changes, and compliant with COSHH (1988) Regulations. To be involved is the compilation and review of Stability documents in line with any changes. Assist in ensuring the unit is fully compliant with the requirements of the executive letter EL(97)52 issued by the department of health. Assist in ensuring the department is fully compliant with the requirements associated with the regulation of clinical trials. Assist the Aseptic Services Manager, their deputy and senior Technicians by acting as a role model and mentor. To contribute to and participate in practise research initiatives within the department. Policy To be involved in the compilation and review of Aseptic Services procedures in line with any changes in legal and ethical policy, Trust developments and local and regional guidance as well as departmental working arrangements. To be involved in ensuring the adherence and upholding of Trust and departmental policies and procedures by the Aseptic Services staff. To ensure confidentiality is maintained at all times. Clinical Governance To ensure that Quality Assurance standards are maintained in accordance with national, regional and local requirements. To assist the Aseptic Services Manager and their deputy in assigned audit activities and produce written reports and statistical information with identified action. To be involved, along with the Aseptic Services Manager and their deputy, in ensuring that the annual validation activities are carried out. To help to ensure staff within the ASU work within the policies and procedures in order to provide a safe, efficient, patient centred aseptic service. To help to ensure that all quality exceptions are documented and appropriate action is taken to resolve any issues raised. To assist the Aseptic Services Manager and their deputy to maintain systems which monitor, evaluate and report aseptic service errors and incidents and implement effective CAPAs. To be involved in ensuring the aseptic services support the developments of other pharmacy services and comply with relevant statutory and ethical guidance by taking an active role in departmental meetings. Ensure appropriate change control processes are followed and authorise changes to any existing product/process or the implementation of any new product or process. Assist the Aseptic Management Team with the management of out of specifications and product/process deviations relating to Aseptic Services. Ensure that any complaints are dealt with promptly and effectively to the satisfaction of both parties and that necessary documentation is completed. Education and Training To maintain and develop specialist knowledge of Aseptic Services and Quality Assurance, attending relevant training. Maintain specialist knowledge with relevant professional and policy developments relating to aseptic services. To be involved in ensuring that all Aseptic Services staff, including bank and locum staff while working in the ASU, are trained and validated and annual assessments are carried out. To be involved in developing and maintaining training programmes and competency assessments of Aseptic Services staff, including rotational pharmacists; organising and coordinating the work of rotational pharmacists within Aseptic Services. To undertake, and encourage others to undertake, continual professional development (CPD) in order to continually update pharmaceutical knowledge and to maintain inclusion on the Pharmacy Register. To be involved in ensuring the competency based aseptic services training of all aseptic staff. To develop and maintain an expertise and knowledge in issues related to aseptic services and the training and development of staff. Person Specification Qualifications Essential Masters Degree in Pharmacy Registered with the General Pharmaceutical Council (Pharmacist). Evidence of up to date CPD Desirable Postgraduate diploma in clinical pharmacy Experience Essential Experience of hospital pharmacy service delivery, either from employment within the hospital service, or by working closely with it. Desirable Experience in an aseptic preparation environment. Experience working with clinical trials within an aseptic environment. Experience of the greater hospital environment. Experience of writing and developing SOPs Experience of staff training and development Skills Essential Good written and oral communication skills Ability to prioritise workload Time management skills Ability to work under pressure whilst maintaining attention to detail and accuracy Self-motivating with good organisational skills Ability to work on own initiative and as part of a team Desirable Able to supervise and direct junior staff Problem solving skills Teaching/tutoring/mentoring skills Ability to affect and manage change Knowledge Essential Knowledge of GMP and Farwell. Understanding the need for confidentiality Knowledge of Health and Safety at Work Act Knowledge of Data Protection Act Knowledge of COSHH Demonstrable awareness of NHS issues Desirable Computer Literate Values Essential Self-motivated. Effective team worker. Ability to work as an individual. Able to cope in a busy environment. Proactive, takes own initiative. Sensitive & supportive. Diplomatic. Assertive. Act as advocate. Strong professional values. Influence senior Pharmacy, Medical & Nursing staff. Can identify own limitations. Able to work under pressure Extremely flexible and reliable Other Essential Participate in out of hours, on-call and Bank Holiday rotas. To cover a shift during the core service hours of 7am until 5pm Person Specification Qualifications Essential Masters Degree in Pharmacy Registered with the General Pharmaceutical Council (Pharmacist). Evidence of up to date CPD Desirable Postgraduate diploma in clinical pharmacy Experience Essential Experience of hospital pharmacy service delivery, either from employment within the hospital service, or by working closely with it. Desirable Experience in an aseptic preparation environment. Experience working with clinical trials within an aseptic environment. Experience of the greater hospital environment. Experience of writing and developing SOPs Experience of staff training and development Skills Essential Good written and oral communication skills Ability to prioritise workload Time management skills Ability to work under pressure whilst maintaining attention to detail and accuracy Self-motivating with good organisational skills Ability to work on own initiative and as part of a team Desirable Able to supervise and direct junior staff Problem solving skills Teaching/tutoring/mentoring skills Ability to affect and manage change Knowledge Essential Knowledge of GMP and Farwell. Understanding the need for confidentiality Knowledge of Health and Safety at Work Act Knowledge of Data Protection Act Knowledge of COSHH Demonstrable awareness of NHS issues Desirable Computer Literate Values Essential Self-motivated. Effective team worker. Ability to work as an individual. Able to cope in a busy environment. Proactive, takes own initiative. Sensitive & supportive. Diplomatic. Assertive. Act as advocate. Strong professional values. Influence senior Pharmacy, Medical & Nursing staff. Can identify own limitations. Able to work under pressure Extremely flexible and reliable Other Essential Participate in out of hours, on-call and Bank Holiday rotas. To cover a shift during the core service hours of 7am until 5pm 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). UK Registration Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window). Additional information 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). UK Registration Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window). Employer details Employer name The Christie NHS FT Address Pharmacy Aseptics - E00921 Manchester M20 4BX Employer's website https://www.christie.nhs.uk/ (Opens in a new tab)