PET Radiotracer Analyst
3 weeks ago
The PET Radiotracer Analyst will be responsible for performing QC method development and routine analysis of PET radiotracers to support clinical and pre-clinical studies at Invicro in a GMP environment.
Key Responsibilities
- Responsible for QC of radiotracers as assigned according to project distribution and the scanning schedule.
- Responsible for QC implementation of new assigned radiotracers: method development, validation and documentation.
- Perform routine QC to support clinical and pre-clinical studies.
- Provide analytical chemistry support for precursor characterization, radiotracer and radioligand purification.
- Data processing including but not limited to HPLC, Ion Chromatography (IC) and GC.
- Documenting QC records to ensure compliance with cGMP.
- Responsible for raising and investigating Out Of Specification (OOS) results and Deviation within QMS.
- Present technical QC issues to internal and external audits, if required.
- Expected to train and educate others in his/her area of expertise.
- Keep up to date with relevant procedures and policies.
- Maintain knowledge regarding new analytical techniques and processes (small molecules and biological products).
- Present results to internal and external audiences, if required.
- Order laboratory supplies to maintain adequate stocks to meet demand.
- Perform basic routine laboratory tasks: prepare HPLC buffers, prepare calibration standards, etc.
- Take responsibility for own work.
- Regularly report results and summaries of own work to line manager.
- Minimum 3 years of experience in QC laboratory.
- Experience in HPLC is a must.
- Experience in a GMP environment is a must.
- Experience in GC is an advantage.
- Experience with short-lived radioisotopes preferable (especially carbon-11 and fluorine-18) is desirable.
- Experience in change control is preferable.
Bachelor's in science
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