Senior Production/QC Radiochemist or Production/QC Radiochemist
We are seeking a Production/QC Radiochemist to 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.
The duties also 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 SOP’s 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 post will be offered on an indefinite contract
This is a full-time post - 100% full time equivalent
• Undertake commissioning, validation, production and QC analysis of PET radiotracers in accordance with GMP procedures.
• Carry out practical validation work for development or GMP compliance as directed by a senior radiochemist.
• Perform routine tests, inspections and maintenance on laboratory equipment and infrastructure.
• Ensure accurate records are maintained of all production, QC, tests, inspections and maintenance work in accordance with SOP’s.
• Participate in a production and QC rota system to cover 05.00 to 18.30 assigned by the Production, QC and Operations manager.
• Comply with local rules for working in a controlled area.
• Follow strict aseptic techniques when working in the isolator hot-cell.
• Communicating technical problems with equipment or processes to other members of the team, cyclotron engineers, clinician’s and to senior members of staff.
• Updating/writing SOP’s, logs and records and investigational reports where and when necessary or as is delegated to ensure they are accurate.
• Scheduling their own priorities to ensure that tasks allocated on a daily or weekly basis are completed as required.
• Perform routine administrative tasks such as ordering and recording of materials as directed.
• Be trained on and apply syntheses/analytical methods for newly introduced radiotracers for research and clinical GMP use.
• Train other staff, researchers or students in production or QC processes as required.
• In the occasional non-availability of senior QC or Production staff, act as the point of contact between the PET production/QC team and the clinical team as appropriate.
• Will actively engage with staff training programmes and be competent to perform at least three different GMP manufacturing processes on different synthesis platforms.
• Will actively engage with Production staff training and be competent to operate the hot-cells, automated synthesis platforms and dispensing platforms.
• Will actively engage with QC staff training programme and be competent to operate all of the QC equipment in the laboratory (including, automatic injection HPLC ((various detectors e.g.: DAD, Conductivity, ECD) MCA detector, GC, TLC etc., PTS) for GMP radiotracer productions.
• Raise Quality Exception Reports as required such as Occurrences, Deviations. Change Controls.
• Will raise Quality Exception Reports and investigate quality exceptions including completing Root Cause Analyses and drafting Quality Exception Reports for approval by QA
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.
Skills, knowledge, and experience
1. 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.
2. Knowledge of PET radiotracer synthesis and QC
3. Radiochemistry/radiopharmacy laboratory experience
4. Practical experience with the production and/or QC of PET Radiopharmaceuticals
5. Knowledge of and proven record in adhering to the principles of GLP and GMP
6. Ability to amend documents eg SOPs
7. Excellent verbal & written communication skills
8. Excellent time keeping
10. Flexible and able to work with a variety of people
11. Flexible approach to hours & duties
12. Ability to work on own initiative and in a multi-disciplinary team
1. Knowledge of Ionising Radiation protection regulations
2. Experience with automated synthesis equipment
3. Experience of production to GMP standards