Job summary
An exciting opportunity has arisen for a highly motivated, qualified pharmacist to join the Pharmacy Directorate and make a significant contribution to improving patient outcomes by providing expert leadership and guidance in the safe use of aseptically prepared cell, gene, and tissue products, supporting both Newcastle Advanced Therapies and the Pharmacy Production Unit. The postholder will support leading international research and clinical services in the aseptic preparation and delivery of innovative advanced therapy medicinal products (ATMPs). The postholder will work with a range of clinical, production and quality assurance professionals to lead the operational requirements to attain and maintain compliance with the Quality Assurance of Aseptic Preparation (QAAPs) standards. The Pharmacy Directorate at Newcastle delivers a comprehensive portfolio of cell and gene therapy services including one of the leading Centre's nationally for CAR-T. This is an exciting opportunity to join an innovative NHS Trust and a multidisciplinary department providing innovative advanced therapies to a broad range of patients.
- Interview Date 03/10/2023
- 37 Hours 30 Minutes/Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
Main duties of the job
The successful candidate will assume the role of accountable pharmacist for Newcastle Advanced Therapies and act as an authorised pharmacists within the Pharmacy Production Unit. The postholder will work closely with a wide network of professionals including scientists, clinicians and pharmacists ensuring appropriate pharmacy directorate oversight is in place for the preparation and delivery of advanced therapy products. The successful candidate will be proactive and self-motivated and be educated to MPharm (or equivalent) level and be able to demonstrate well-developed production pharmacy knowledge and aseptic preparation experience. This is an exciting opportunity for a qualified, registered pharmacist to join an innovative team and apply their knowledge and experience to advanced therapy preparation.
About us
Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with over 18,000 staff and an annual income of £1 billion.
Rated 'Outstanding' by theCQC for the second consecutive time in 2019, we have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 1.84 million patients 'contacts' each year, delivering high standards of healthcare.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Job description
Job responsibilities
- To enhance and improve patient outcomes across the Trust by providing expert pharmaceutical advice and guidance relating to the safe use of high-quality aseptically prepared products, supporting both Newcastle Advanced Therapies and Newcastle Specials.
- To undertake the role of Accountable Pharmacist for Newcastle Advanced Therapies (0.5FTE) within the Cell, Gene, and Tissue Laboratory for the preparation of cell and gene therapy products, ensuring continuity of all aseptic dispensing activities relating to advanced therapies.
- To act in the role of authorised pharmacist (0.5FTE) in Newcastle Specials, particularly in support of Cancer Services and areas of integration with Newcastle Advanced Therapies.
- To support daily, regarding professional pharmaceutical matters, the GMP facilities and infrastructure utilised in the preparation of ATMPs as a licensed therapy or for use as experimental products in clinical trials.
- To ensure the delivery of safe and highly specialist production services to service users.
- To provide direct responsibility for ensuring Newcastle Advanced Therapies is compliant with the Quality Assurance of Aseptic Preparation (QAAPS) standards in relation to the aseptic preparation of advanced therapy products under Section 10 and regulation 37 exemptions.
- To support pharmacy directorate oversight and the development and implementation of pan-pharmacy policies and SOPs associated with capability to deliver safe and appropriate quality products for their intended use.
- To support training programmes for all staff involved in production within the pharmacy directorate and to assess training and delegate authorised responsibilities.
- To collaborate with the Production Manager and Quality Assurance Manager in development of the Quality Management System and contribute to the maintenance of departmental regulation and accreditations.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate.The method of payment is a salary deduction from your first months pay.
Job description
Job responsibilities
- To enhance and improve patient outcomes across the Trust by providing expert pharmaceutical advice and guidance relating to the safe use of high-quality aseptically prepared products, supporting both Newcastle Advanced Therapies and Newcastle Specials.
- To undertake the role of Accountable Pharmacist for Newcastle Advanced Therapies (0.5FTE) within the Cell, Gene, and Tissue Laboratory for the preparation of cell and gene therapy products, ensuring continuity of all aseptic dispensing activities relating to advanced therapies.
- To act in the role of authorised pharmacist (0.5FTE) in Newcastle Specials, particularly in support of Cancer Services and areas of integration with Newcastle Advanced Therapies.
- To support daily, regarding professional pharmaceutical matters, the GMP facilities and infrastructure utilised in the preparation of ATMPs as a licensed therapy or for use as experimental products in clinical trials.
- To ensure the delivery of safe and highly specialist production services to service users.
- To provide direct responsibility for ensuring Newcastle Advanced Therapies is compliant with the Quality Assurance of Aseptic Preparation (QAAPS) standards in relation to the aseptic preparation of advanced therapy products under Section 10 and regulation 37 exemptions.
- To support pharmacy directorate oversight and the development and implementation of pan-pharmacy policies and SOPs associated with capability to deliver safe and appropriate quality products for their intended use.
- To support training programmes for all staff involved in production within the pharmacy directorate and to assess training and delegate authorised responsibilities.
- To collaborate with the Production Manager and Quality Assurance Manager in development of the Quality Management System and contribute to the maintenance of departmental regulation and accreditations.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate.The method of payment is a salary deduction from your first months pay.
Person Specification
Qualifications & Education
Essential
- M Pharm (or equivalent) degree course and pre-registration experience/training
- Registered Pharmacist (GPhC) for CPD
Desirable
- Evidence of further education or higher qualification related to Pharmaceutical Technology and / or Quality Assurance; Management; Clinical
- Completion of recognised Aseptic Course for managers - Aseptic Dispensing for Managers
Knowledge & Experience
Essential
- Evidence of continuing professional development (CPD)
- Well-developed production pharmacy knowledge across all aspects of medicine preparation
- Knowledge of pharmaceutical audit and its role in pharmacy aseptic dispensing
- Extensive practical and theoretical knowledge of Good Manufacturing Practice (Rules & Guidance for Pharmaceutical Manufacturers and Distributors) including section 10 and regulation 37 exemption
- Extensive post registration experience in hospital pharmacy, some of which must be working in a hospital licensed production and/ or unlicensed preparation unit
- Demonstrate they have been involved in the area of clinical audit
- Well-developed knowledge of aseptic technique, contamination control and environmental monitoring
- Understanding of the operation, validation, and maintenance of specialist equipment associated with a GMP compliant production unit including, Air Handling Unit, Laminar flow cabinets, Safety Cabinets and Negative pressure containment devices.
- Audit of services by external auditing organisation i.e., MHRA and / or Regional Quality Assurance Specialist
- Knowledge of validation programmes including documentation and QA systems
Desirable
- Organisation of and undertaking training and appraisal of technical, professional and support staff.
- Senior management experience
- Experience of clinical trials in a hospital environment
- Experience in the aseptic preparation of cell, gene, or tissue products
- Clinical Pharmacy experience
- Working Knowledge of the HTA for the handling and storage of cells and tissues
- Knowledge and experience of advanced therapies
Skills & Abilities
Essential
- Excellent communicator - verbal & written specialist information
- One to one communication
- Good organisational and management skills
- Influencing and negotiation skills
- Well-developed mentoring skills
- Basic computer skills
Desirable
- Leading meetings
- Small Group Skills
Person Specification
Qualifications & Education
Essential
- M Pharm (or equivalent) degree course and pre-registration experience/training
- Registered Pharmacist (GPhC) for CPD
Desirable
- Evidence of further education or higher qualification related to Pharmaceutical Technology and / or Quality Assurance; Management; Clinical
- Completion of recognised Aseptic Course for managers - Aseptic Dispensing for Managers
Knowledge & Experience
Essential
- Evidence of continuing professional development (CPD)
- Well-developed production pharmacy knowledge across all aspects of medicine preparation
- Knowledge of pharmaceutical audit and its role in pharmacy aseptic dispensing
- Extensive practical and theoretical knowledge of Good Manufacturing Practice (Rules & Guidance for Pharmaceutical Manufacturers and Distributors) including section 10 and regulation 37 exemption
- Extensive post registration experience in hospital pharmacy, some of which must be working in a hospital licensed production and/ or unlicensed preparation unit
- Demonstrate they have been involved in the area of clinical audit
- Well-developed knowledge of aseptic technique, contamination control and environmental monitoring
- Understanding of the operation, validation, and maintenance of specialist equipment associated with a GMP compliant production unit including, Air Handling Unit, Laminar flow cabinets, Safety Cabinets and Negative pressure containment devices.
- Audit of services by external auditing organisation i.e., MHRA and / or Regional Quality Assurance Specialist
- Knowledge of validation programmes including documentation and QA systems
Desirable
- Organisation of and undertaking training and appraisal of technical, professional and support staff.
- Senior management experience
- Experience of clinical trials in a hospital environment
- Experience in the aseptic preparation of cell, gene, or tissue products
- Clinical Pharmacy experience
- Working Knowledge of the HTA for the handling and storage of cells and tissues
- Knowledge and experience of advanced therapies
Skills & Abilities
Essential
- Excellent communicator - verbal & written specialist information
- One to one communication
- Good organisational and management skills
- Influencing and negotiation skills
- Well-developed mentoring skills
- Basic computer skills
Desirable
- Leading meetings
- Small Group Skills
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.
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.
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).
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