Pharmaceutical Chemistry Evaluator
The responsibilities of the Branch include:
- Evaluation of the pharmaceutical chemistry (in particular quality and bioequivalence) of new prescription medicines for market authorisation and applications to vary these aspects of approved medicines.
- Assessment of the pre-clinical toxicology of medicines and other products to enable decisions to be made on the risks and benefits of these products.
- Regulation of blood and biologicals (human cell and tissue therapies), including aspects of infectious disease safety.
- Provision of scientific advice to other branches and divisions, in particular to support the clinical evaluation of prescription medicines and post-market activities and
- Delivery of existing reform projects.
Possibility of extension
Full-time (37.5 hours per week)
Canberra – preferred, other locations will be considered
Duties of position
Specific duties include:
- Examine the chemistry, quality control, and bioavailability data supplied by pharmaceutical companies in support of submissions to the Department.
- Prepare reports which summarise and provide an independent scientific assessment of the data submitted.
- Prepare and send correspondence to the company following assessment of the data submitted. Recommend acceptance or rejection with respect to chemistry, quality control and bioavailability. Specify how any deficiencies in the submission may be remedied.
- Undertake special projects as required or directed by the supervisor and Pharmaceutical Chemistry Section Director.
- This position requires knowledge of, and experience with, chemistry, pharmaceutical standards, pharmacokinetics and bioavailability, preferably in a regulatory environment.
Candidates must hold:
- A degree in science, preferably in chemistry, pharmaceutical science, or related discipline from an Australian tertiary institution, or comparable overseas qualification.
- Postgraduate qualifications are highly desirable, with a focus on organic synthesis, pharmaceutical product development, modern analytical techniques or bioavailability/bioequivalence.
If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
0403 200 666
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