Job summary
This
position presents an exciting opportunity for an experienced radiochemist or
radiopharmacist proficient in PET radiopharmaceutical production to GMP
standards. As the Production Manager, you will lead our team of radiochemists
at the Positron Emitting Radiopharmaceutical Laboratory (PERL), located within
St Thomas Hospital.
The ideal candidate must possess expert knowledge in relevant regulatory governance areas, particularly Good Manufacturing Practice (GMP), as well as Health and Safety, Environmental Safety, and Radiation Protection Regulations (IRR2017 and IR(ME)R). This expertise will ensure adherence to these regulations within the PERL facility.
Main duties of the job
The role entails managing radiochemists
within PERL to ensure timely, safe, and efficient completion of production
duties. Emphasis will be placed on compliance with GMP regulations, development
of new procedures and radio tracers, and streamlining processes while
maintaining safety standards. This includes supporting the installation and
validation of new production equipment.
The successful candidate will be an
integral part of the PERL senior team, collaborating with the PERL Operations
Manager, PET Service Manager, and other senior members to ensure smooth project
and daily production operations. Reporting to the PET Operational Manager, they
may also deputize at senior meetings when necessary.
The Production Manager role demands
strong prioritization and organizational skills to manage multiple projects
simultaneously and direct the radiochemist team in producing routine
radiopharmaceuticals and developing new radiotracers.
Additionally, the post holder will
contribute to education and training initiatives for PERL staff, researchers,
and students from the School.
This position requires
on-site presence at St Thomas Hospital and flexibility to meet service needs.
It is a full-time role (35 hours per week) with an indefinite contract offered.
About us
The
PERL facility plays a crucial role in the clinical PET center, serving over
8,000 patients and research participants annually from South-East London and
beyond. It is an integral part of both King's College London's School of
Biomedical Engineering and Imaging Sciences and Guy's & St Thomas' National
Health Service (NHS) Foundation Trust. Our PET Center relies heavily on the
PERL facility for the supply of radiopharmaceuticals and this is likely to
become increasingly important when the new Total Body PET scanner is installed
later this year.
Comprising two GMP clean
rooms, a QC laboratory, and an R&D laboratory with a total of 24 hot cells,
the PERL facility is equipped with a PETtrace high-energy cyclotron and various
dispensing units, calibrators, and analysis equipment. It operates under a
Specials manufacturing license, currently producing [18F]fluorodeoxyglucose
(FDG) and [11C]methionine routinely, with ongoing development of
additional radiotracers. We anticipate the availability of two more
radiotracers for routine and research use by the end of 2024, with plans to
expand the portfolio by two to three radiotracers annually.
Job description
Job responsibilities
Key
responsibilities
-
Implement
a robust regime for the reliable production of PET radiotracers for clinical
and research use
-
Organising
day-to-day production of radiopharmaceuticals against agreed schedules and
standard operating procedures
-
Organise
rotas and appropriate cover of PET radiochemistry staff for production of
radiopharmaceuticals in conjunction with the Operations Manager, QC Manager and
Development Manager
-
Ensure
appropriate maintenance of production-related instrumentation and
infrastructure is performed and documented appropriately.
-
Oversight
and documentation of raw material utilisation and traceability for production
purposes in conjunction with the QC manager and QA function.
-
Close
liaison with Operations manager, QC and Development Managers/Leads for smooth
running of the radiotracer productions
-
Close
liaison with the Development Manager/Lead in the implementation of new
radiotracers to schedule and within financial and human resource constraints
-
Be
proactive and responsible, to ensure that regulatory and technical problems are
solved and do not present barriers to the production of radiotracers.
-
Enable
the implementation of new and established PET chemistry and PET radiotracers
for clinical and research use
-
The
post holder will report to the Operations Manager for logistical and planning
aspects of the job role: e.g. organising team rotas, production schedules,
maintenance and validation schedules, and operational issues. The post holder
will also contribute to the strategic, scientific and long term planning of
radiochemistry in conjunction with the Operations Manager.
-
Responsibly
communicate with QA function/pharmacists/QPs, chemists, scientists and
clinicians involved in radiopharmaceutical production and utilisation.
-
Report
any deficiencies in the production of radiopharmaceuticals to the Operations
Manager in a timely manner
-
Be
responsible for communication with other scientific and technical staff to
solve technical problems in a timely manner
-
The
post holder will be required to work with minimum supervision. They must therefore be able to manage their
own time and workload efficiently and effectively. This also requires a
methodical approach with a flexible and adaptable approach to work. They will
interlink with other areas of the PET Centre and research groups within KCL and
the School of Biomedical Engineering and Imaging Sciences and will be required
to communicate with them effectively.
-
The
post holder will be expected to assist in the training of both radiochemists
within the PERL team and researchers, students, staff using the facility or
gaining experience of the facility.
-
The
post holder will be directly responsible for a team of radiochemists working in
PERL and will act as their line manager.
The above list of
responsibilities may not be exhaustive, and the post holder will be required to
undertake such tasks and responsibilities as may reasonably be expected within
the scope and grading of the post.
Job description
Job responsibilities
Key
responsibilities
-
Implement
a robust regime for the reliable production of PET radiotracers for clinical
and research use
-
Organising
day-to-day production of radiopharmaceuticals against agreed schedules and
standard operating procedures
-
Organise
rotas and appropriate cover of PET radiochemistry staff for production of
radiopharmaceuticals in conjunction with the Operations Manager, QC Manager and
Development Manager
-
Ensure
appropriate maintenance of production-related instrumentation and
infrastructure is performed and documented appropriately.
-
Oversight
and documentation of raw material utilisation and traceability for production
purposes in conjunction with the QC manager and QA function.
-
Close
liaison with Operations manager, QC and Development Managers/Leads for smooth
running of the radiotracer productions
-
Close
liaison with the Development Manager/Lead in the implementation of new
radiotracers to schedule and within financial and human resource constraints
-
Be
proactive and responsible, to ensure that regulatory and technical problems are
solved and do not present barriers to the production of radiotracers.
-
Enable
the implementation of new and established PET chemistry and PET radiotracers
for clinical and research use
-
The
post holder will report to the Operations Manager for logistical and planning
aspects of the job role: e.g. organising team rotas, production schedules,
maintenance and validation schedules, and operational issues. The post holder
will also contribute to the strategic, scientific and long term planning of
radiochemistry in conjunction with the Operations Manager.
-
Responsibly
communicate with QA function/pharmacists/QPs, chemists, scientists and
clinicians involved in radiopharmaceutical production and utilisation.
-
Report
any deficiencies in the production of radiopharmaceuticals to the Operations
Manager in a timely manner
-
Be
responsible for communication with other scientific and technical staff to
solve technical problems in a timely manner
-
The
post holder will be required to work with minimum supervision. They must therefore be able to manage their
own time and workload efficiently and effectively. This also requires a
methodical approach with a flexible and adaptable approach to work. They will
interlink with other areas of the PET Centre and research groups within KCL and
the School of Biomedical Engineering and Imaging Sciences and will be required
to communicate with them effectively.
-
The
post holder will be expected to assist in the training of both radiochemists
within the PERL team and researchers, students, staff using the facility or
gaining experience of the facility.
-
The
post holder will be directly responsible for a team of radiochemists working in
PERL and will act as their line manager.
The above list of
responsibilities may not be exhaustive, and the post holder will be required to
undertake such tasks and responsibilities as may reasonably be expected within
the scope and grading of the post.
Person Specification
Experience
Essential
- Radiochemistry research laboratory experience
- Practical experience with the production of PET radiopharmaceuticals and associated techniques including experience with automated synthesis equipment
- Experience with a range of radionuclides
Desirable
Qualifications
Essential
- PhD in Chemistry, Pharmacy or related discipline or equivalent experience
Knowledge and skills
Essential
- Knowledge of PET and/or SPECT radiotracer synthesis
- Knowledge of Ionising Radiation protection regulations
- Knowledge of and proven record in adhering to the principles of GLP and GMP and experience of production to GMP standards
- Ability to draft documents e.g. SOPs
Desirable
- Excellent verbal & written communication skills
- Ability to work on own initiative and in a multi-disciplinary team
- Able to handle several projects at once and prioritise
- Ability to act on personal initiative and take responsibility for own work and ensuring projects are completed
Person Specification
Experience
Essential
- Radiochemistry research laboratory experience
- Practical experience with the production of PET radiopharmaceuticals and associated techniques including experience with automated synthesis equipment
- Experience with a range of radionuclides
Desirable
Qualifications
Essential
- PhD in Chemistry, Pharmacy or related discipline or equivalent experience
Knowledge and skills
Essential
- Knowledge of PET and/or SPECT radiotracer synthesis
- Knowledge of Ionising Radiation protection regulations
- Knowledge of and proven record in adhering to the principles of GLP and GMP and experience of production to GMP standards
- Ability to draft documents e.g. SOPs
Desirable
- Excellent verbal & written communication skills
- Ability to work on own initiative and in a multi-disciplinary team
- Able to handle several projects at once and prioritise
- Ability to act on personal initiative and take responsibility for own work and ensuring projects are completed
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).
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).