Senior Production/QC Radiochemist

Job description

Job responsibilities

• Key Responsibilities:
• 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.
• 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 SOPs.
• Participate in a production and QC rota system to cover 05.00 to 18.30 assigned by the Production, QC and Operations manager. Time schedule may vary due to service need and changes will be subject to consultation.
• 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, clinicians and to senior members of staff.
• Updating/writing SOPs, 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 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.
• After appropriate training, being able to operate the PET Trace Cyclotron for production of radionuclides to be used in synthesis processes
• 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.

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.

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 (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).

Employer details

Employer name

Kings College London

Address

St. Thomas's Hospital

249 Westminster Bridge Road

London

SE1 7EH

Employer's website

https://www.kcl.ac.uk (Opens in a new tab)