09 Oct
KINGS COLLEGE LONDON
London
Job description
Job summary
The Senior Production / QC Radiochemist will work as part of a team of radiochemists involved in the production and / or QC of radiopharmaceuticals in accordance with GMP requirements to set production schedules
Main duties of the job
- Duties include the development of new tracers by performing practical validation work as directed by more senior radiochemists;
- to support GMP compliance by performing practical validation work and updating SOPs as directed by more senior radiochemists;
and to support the training of other staff members, performing routine tasks and administrative work and acting as the contact with the clinical team on occasions when the need arises or is assigned to.
This is a full time post (35 Hours per week), and you will be offered an indefinite contract.
About us
The PET Centre is part of Guys and St Thomas NHS Foundation Trust and Kings College London within the School of Biomedical Engineering & Imaging Sciences.
The Positron Emitting Radiopharmaceutical Laboratory (PERL) plays a crucial role in the clinical PET Centre, 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 :
- Dutiesinclude the development of new tracers by performing practical validation workas directed by more senior radiochemists;
- to support GMP compliance byperforming practical validation work and updating SOPs as directed by moresenior radiochemists;
and to support the training of other staff members,performing routine tasks and administrative work and acting as the contact withthe clinical team on occasions when the need arises or is assigned to.
- Undertakecommissioning, validation, production and QC analysis of PET radiotracers inaccordance with GMP procedures.
- Carryout practical validation work for development or GMP compliance as directed bya senior radiochemist.
- Performroutine tests, inspections and maintenance on laboratory equipment andinfrastructure.
- Ensureaccurate records are maintained of all production, QC, tests, inspections andmaintenance work in accordance with SOPs.
- Participatein a production and QC rota system to cover to assigned by theProduction, QC and Operations manager.
Time schedule may vary due to serviceneed and changes will be subject to consultation.
- Complywith local rules for working in a controlled area.
- Followstrict aseptic techniques when working in the isolator hot-cell.
- Communicatingtechnical problems with equipment or processes to other members of the team,cyclotron engineers, clinicians and to senior members of staff.
- Updating / writingSOPs, logs and records and investigational reports where and when necessary oras is delegated to ensure they are accurate.
- Schedulingtheir own priorities to ensure that tasks allocated on a daily or weekly basisare completed as required.
- Performroutine administrative tasks such as ordering and recording of materials asdirected.
- Betrained on and apply syntheses / analytical methods for newly introducedradiotracers for research and clinical GMP use.
- Trainother staff, researchers or students in production or QC processes as required.
- Inthe occasional non-availability of senior staff, act as the point of contactbetween the PET production / QC team and the clinical team as appropriate.
- Willactively engage with staff training programmes and be competent to perform atleast three different GMP manufacturing processes on different synthesisplatforms.
- Willactively engage with Production staff training and be competent to operate thehot-cells, automated synthesis platforms and dispensing platforms.
- Willactively engage with QC staff training programme and be competent to operateall of the QC equipment in the laboratory (including, automatic injection HPLC(various detectors DAD,Conductivity, ECD) MCA detector, GC, TLC etc.
PTS) for GMP radiotracerproductions.
- Afterappropriate training, being able to operate the PET Trace Cyclotron forproduction of radionuclides to be used in synthesis processes
- RaiseQuality Exception Reports as required such as Occurrences, Deviations. ChangeControls.
- Willraise Quality Exception Reports and investigate quality exceptions includingcompleting Root Cause Analyses and drafting Quality Exception Reports forapproval by QA
The above list ofresponsibilities may not be exhaustive,
and the post holder will be required toundertake such tasks and responsibilities as may reasonably be expected withinthe scope and grading of the post.
Person Specification
Knowledge and skills
Essential
- Knowledge of and proven record in adhering to the principles of GLP and GMP
- Ability to amend documents eg SOPs
- Excellent verbal & written communication skills
- Excellent time keeping, reliable, Flexible and able to work with a variety of people with a Flexible approach to hours & duties and ability to work on own initiative and in a multi-disciplinary team
Experience
Essential
- Knowledge of PET radiotracer synthesis and QC
- Radiochemistry / radiopharmacy laboratory experience
- Practical experience with the production and / or QC of PET Radiopharmaceuticals
Desirable
- Knowledge of Ionising Radiation protection regulations
- Experience with automated synthesis equipment
- Experience of production to GMP standards
Qualifications
Essential
- Degree in chemistry or pharmacy OR Broad vocational experience, acquired through a combination of job-related vocational training and considerable on the job experience, demonstrating development through involvement in a series of progressively more demanding relevant work / roles.