In this role you'll perform QC method development and routine analysis of PET radiotracers to support clinical and pre-clinical studies in a GMP environment.
QC of assigned radiotracers according to project distribution and the scanning schedule.
QC implementation of newly assigned radiotracers: method development, validation and documentation.
Providing routine QC support to clinical and pre-clinical studies.
Providing analytical chemistry support for precursor characterization, radiotracer and radioligand purification.
Data processing including HPLC and GC.
Documenting QC records to ensure compliance with cGMP.
Raising and investigating Out Of Specification (OOS) results and Deviation within QMS.
Presenting technical QC issues to internal and external audits, if required.
Training and educating others in your area of expertise.
Keeping up to date with relevant procedures and policies, as well as new analytical techniques and processes (small molecules and biological products).
Presenting results to internal and external audiences, when required.
Maintaining adequate stocks of laboratory supplies
Completing routine laboratory tasks, e.g., preparing HPLC buffers, calibration standards, etc.
