JOB SUMMARY

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.

REQUIRED SKILLS:

• Minimum 2 years’ experience in a QC laboratory.
• Experience in HPLC
• Experience in a GMP environment

KNOWLEDGE AND PREFERRED SKILLS:

• Experience in GC is an advantage.
• Experience working with short-lived radioisotopes preferable (especially carbon-11 and fluorine-18) is desirable.
• Experience in change control is preferable.

EDUCATION:

• Undergraduate degree in Chemistry or a related scientific discipline

• 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.