Senior Microbiologist
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 Senior Microbiologist to join our Quality Compliance team. Working with the QC team you will be involved in setting up Micro and PC2 laboratory.
Reporting to the Quality Control Manager, this newly created Senior Microbiologist role is an important addition to our expanding team here in Sydney as we experience rapid growth across the organisation. You will be developing and performing microbiological and biochemical analysis of in process, finished product and incoming raw materials and utility samples. We are looking for a highly organised and focused team player who understands the importance of delivering on time and contributing to our success...!
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 amp; ICH)
- Undertaking IQ, OQ, PQ
- Conducting method development and validation on Microbiology equipment
- Working closely with other departments to ensure all activities are completed
- Manage the performance of validation activities associated with changes to existing and new processes
- Developing and assessing microbiological testing procedures of materials and products, ensuring all GMP, safety, corporate, regulatory and legislative compliance requirements are met
- Managing audit preparations and providing support to defend areas of validation
- Monitoring the environment for signs on contamination such as mould growth or elevated bacteria counts
- Developing and assessing the maintenance, updating and validation of procedures involving environmental monitoring, equipment cleaning and sanitization
- Flexible to work is shifts across the day on a rotating roster
- Performing any other duties assigned by manager or delegates.
Requirements
What we would expect from you:
- A Bachelor of Science degree majoring in Microbiology or related fields
- Demonstrated experience working within the pharmaceutical industry
- Proven experience within method development and validation in Microbiology
- Excellent written and verbal communication skills
- The ability to work independently.
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...!