QC Chemist
Aegros Therapeutics Pty Ltd, Australia
Job Description
Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.
Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collected into life saving hyperimmune products.
It's no secret that Aegros is expanding rapidly! An exciting opportunity has arisen for a QC Chemist to join our Quality Compliance team. Working with the QC team you will be primarily focussing on method validation and development activities.
Reporting to the Quality Control Manager, you will work on microbiological, chemical and biochemical analysis of In process, finished products and incoming raw materials and utility samples.
What you will be involved in
- Planning and executing method validation, verification, and improvements to method functionality
- Generating validation protocols and reports ensuring practices meet regulatory standards (TGA, ICH)
- Carrying out quantitative determination using various analytical instrumentation techniques such as HPLC/GC, ICP-MS, physical testing (e.g. Karl Fischer, viscometer), wet chemistry (e.g. Titration)
- Conducting raw material analysis following monograph methods, instrumental, physical and wet chemistry methods
- Developing stability indicating analytical methods for determination of active pharmaceuticals and related substances
- Maintaining compliance of the analytical service with the principles of Good Manufacturing Practice (GMP) and Good Laboratory Practices (GLP)
- Conduct method development and validation on analytical equipment including undertaking equipment qualification IQ,OQ, PQ
- Manage the performance of validation activities associated with changes to existing and new processes
- Calibrating and maintaining lab equipment
- Managing audit preparations and provide support in areas of validation
- Supporting in training, testing, sampling of Raw Materials/Finished Products and other QC related work as required.
- Performing any other duties assigned by manager or delegates
- Flexible to work is shifts across the day on a rotating roster.
Requirements
What we would expect from you:
- A Bachelor of Science degree preferably within Chemistry, Pharmaceutical sciences or related fields
- 2-4 years’ experience in microbiological testing and analysis in QC laboratory as an analyst in pharmaceutical or related industries
- Demonstrated experience within chromatographic method development and validation to ICH standards
- Prior exposure to cGMP manufacturing environment
- Good verbal and written communication skills;
- Good record keeping skills;
- Attention to detail, careful and conscientious;
- Ability to meet and exceed targets;
- Ability to work well in a team
- Able to work in shifts as required.
Benefits
Here’s what we can offer you
- An environment which allows the individual to grow alongside the company
- A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do
- The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved
- A multicultural environment where every voice is heard
- Competitive remuneration package which includes an annual Bonus + Employee Share Options
- Close to public transport
Interested? Apply today...!