PET QC Chemist

at  Perceptive

JOB SUMMARY

The key responsibilities of this role are to perform QC method development and routine analysis of PET radiotracers to support clinical and pre-clinical studies at Invicro in a GMP environment.

REQUIRED SKILLS:

• Minimum 3 years of experience in QC laboratory.
• Experience in HPLC is a must.
• Experience in a GMP environment is a must.

KNOWLEDGE AND PREFERRED SKILLS:

• 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.

EDUCATION:

Bachelor’s in scienc

• 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.
• To 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.
• Will be expected to train and educate others in his/her area of expertise.
• Keeping up to date with relevant procedures and policies.
• Keeping knowledge up to date regarding new analytical techniques and processes (small molecules and biological products).
• Presentation of results to internal and external audiences, if required.
• Ordering of laboratory supplies to maintain adequate stocks to meet demand.
• Basic routine laboratory tasks: prepare HPLC buffers, prepare calibration standards, etc.
• Responsibility for own work.
• Regularly reporting of results and summaries of own work to line manager.