Radiopharmacy Production Manager

Job description

Job responsibilities

Contribute to relevant business cases, financial planning and clinical governance where new service developments are proposed.

Together with the Head of Nuclear Medicine and the trusts GMP Quality controller act as the Trust expert for the safe use and introduction of all radiopharmaceuticals.

Manage specialist staff rotas/leave arrangement to ensure that the level of service required by the stakeholders is satisfied in a timely manner taking into account skill mix and radiopharmaceutical supply.

Manage the purchase, stock, manufacture and dispensing of all radiopharmaceuticals (and other associated consumables) in a safe, efficient and timely manner and in accordance with stakeholders requirements and MHRA Manufacturing Licence (Specials).

Plan, manage and organise the complex supply of all radiopharmaceutical consumables and other materials to ensure supplies are adequate (but not excessive) to meet the demands of the Radio pharmacy service ensuring that this is within the limits of all Environmental Permits held by the Trust.

Participate in contract negotiations and official European tender processes for the purchase of services, equipment and radioactive and non-radioactive pharmaceuticals.

Ensure all radiopharmaceutical, consumables and other materials/equipment are stored under suitable conditions within the Radio pharmacy and support facilities. Maintain adequate continuous monitoring systems and review monitoring data. Perform temperature and pressure mapping and transport validations as required.

Ensure all hazards associated with handling radioactive materials in the Radio pharmacy are minimized by appropriate equipment layout, staff training and regular monitoring for radioactive contamination of surfaces.

Act as the department Radiation protection supervisor

In conjunction with Senior Nuclear Medicine staff, ensure radiation protection principles are appropriately applied to all aspects of work undertaken in the Radio pharmacy.

Be responsible for managing all aspects of the operational environment in the Radio pharmacy and liaison with the trust hard / soft services providers and external contractors / suppliers; ensuring all equipment is serviced, facilities validated and environmental specifications met.

Together with trust partners, plan and manage the service in response to physical environment changes and complex developments including the life-cycling of the unit. This includes the complex management of radioactive materials, external supply, contracts and costs to enable continuing source of these essential materials for the Nuclear Medicine service.

Ensure that all record keeping and monitoring is carried out to confirm adherence to Radio pharmacy standard operating procedures. This includes records of raw materials and manufacturing procedures contributing to complex radiopharmaceutical manufacture or dispensing.

Participate in the manufacture of complex radiopharmaceuticals including the synthesis of99mTc and other radiopharmaceuticals. This requires maintenance of competency in aseptic manipulation.

Release manufactured radiopharmaceuticals for administration to patients, rejecting products where the standards are not met. Check dispensed radiopharmaceuticals for accuracy.

Liaise with scientific, medical, nursing and support staff; exchanging very complex information relevant to the patients investigation.

Ensure with the quality controller that an effective quality assurance programmes in place.

Manage the Radio pharmacy quality management system, ensuring all relevant documentation is written, distributed and reviewed.

Review and maintain Quality Control Standard Operating Procedures (SOPs), and approve other SOPs e.g. handling of radioactive waste. Contribute and review relevant Trust policies e.g. medicines management.

Take a leading role in both internal and external audit/inspections of the Radio pharmacy service including those undertaken routinely by the MHRA. Devise and implement measures to correct non-compliances identified by audit/inspection.

Undertake appropriate action/investigation in line with MHRA requirements for all deviations, product recalls and change control (as and when required) ensuring that this is documented fully.

In conjunction with the Head of Nuclear Medicine, oversee the renewal of contracts/pricing arrangements for all radiopharmaceuticals and associated drugs.

Manage, supervise and train staff (Clinical Technologists/Clinical Scientists/Pharmaceutical Scientists/Pharmacists) undertaking work in the Radio pharmacy. This includes training and supervising appropriately experienced staff to undertake the manufacture, release or dispensing of radiopharmaceutical products prepared under an MHRA License (Specials) and associated products.

Train and supervise other staff (Domestic/ Engineering) required to work within the Radio pharmacy.

Ensure that all training plans are in place and training is completed in a timely manner, regularly reviewed and outcomes documented.

Appraise the performance of members of the Radio pharmacy staff by agreeing and reviewing their personal development plans.

Participate in staff recruitment, development, and performance reviews.

Define appropriate training programmes and regularly deliver training to groups of staff and students, including both teaching and evaluation.

Describe the technical operation of the radio pharmacy and procedures to students and non-technical personnel.

Promote and assist in providing a wide and varied CPD program for all technologists.

Lead the capital equipment process for high value equipment within the Radio pharmacy including the generation of tendering paperwork, evaluation and selection.

Provide a Radio pharmacy service to external units (e.g. other NHS Trusts) when required under a specified Service Level Agreement.

Undertake research and development activities including the organisation, performance and supervision of research projects and the presentation of findings.

As part of personal development, participate in appropriate training and development activities.

Undertake any other duties in the Radio pharmacy or Nuclear Medicine department as directed by the Head of Nuclear Medicine and in line with training and competence.

Person Specification

Educations, Training and Qualifications

• Educated to degree level in relevant field or equivalent level of education, training or experience. Educated to Masters level in relevant field or equivalent level of education, training or experience
• Educated to Masters level in relevant field or equivalent level of education, training or experience

• Formal training in Radiopharmacy, Pharmaceutical Production & Quality Control

Knowledge and Experience

• Extensive post-qualification experience of aseptic radiopharmaceutical production (sufficient to meet MHRA requirements for a Radiopharmacy production manager in a licensed specials unit).
• An in depth knowledge of the technical aspects of Radiopharmacy (& Nuclear Medicine) and a good scientific knowledge (degree level).
• An in depth knowledge of the theory and practice of radiopharmaceutical production
• Detailed knowledge of Good Manufacturing Practice (GMP)
• An in depth knowledge of the practices and procedures associated with the use of radiopharmaceuticals for routine nuclear medicine investigations
• A good knowledge of the relevant anatomy and physiology and radiopharmaceutical bio-kinetics associated with routine nuclear medicine investigations.
• Sufficient understanding of the legislation and guidelines associated with the medical use of radioactive substances so as to ensure safe working practice.
• Experience in Clinical Nuclear Medicine
• Supervisory experience of junior staff and trainees
• Understanding of relevant health and safety regulations.
• Experience in Managing & Maintaining a Quality Management System

• Knowledge of clean room design, equipment and function.
• Understanding of Validation & Quality guidance including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
• GCP knowledge and training
• RPS training

Skills

• Able to prioritise workload/flow of Leaders and team workers, methodical and organised, self-motivated and able to motivate others.
• Planning highly complex activities to meet the needs of the stakeholder service in a timely manner
• Manage staff performing complex skilled procedures (radiopharmaceutical production).
• Supervision of clinical technology staff (trained and in-training) and other workers.
• Relay highly complex scientific information to a range of staff groups including medical staff, scientists, technologists and others.
• Teach and train all staff in the use of highly complex equipment and intricate processes defined within written SOPs
• Produce clear written reports and SOPs for the safe and appropriate use of the unit.
• Able to acquire, analyse and collate highly complex scientific data for reports and presentations.
• Daily preparation, handling, dispensing and administration of hazardous materials including a wide range of radiopharmaceuticals
• Highly developed physical skills, requiring high levels of dexterity, accuracy and co-ordination, to manufacture materials for patient administration in an aseptic and radiation safe manner. Ability to work at speed with precision and routinely handle concentrated radioactive liquids.
• Procurement and management of non-returnable radiopharmaceuticals
• Maintenance and management of consumable items in a cost effective manner while ensuring adequate provision for patient procedures, prioritising and planning own patient workload
• Supervision of visiting medical, nursing and scientific personnel while observing/training within radioactive Controlled Areas
• Derive diagnostic results from multiple data entries into very complex numerical formulae, spreadsheets or databases
• Produce a written documents describing an imaging or non-imaging procedure

Key Competencies/Personal Qualities and Attributes

• Passionate and committed to bring our Dedicated to Excellence values to life, improving the way we work with each other, particularly focusing on empowerment, equality diversity and inclusion of our staff, patients and service users

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.

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.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website.

Employer details

Employer name

Northampton General Hospital

Address

Northampton General Hospital NHS TRUST

Cliftonville

Northampton

NN1 5BD

https://www.northamptongeneral.nhs.uk/Home.aspx