About Aegros

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 permanent full time Manufacturing Science & Technology Engineer responsible for process development, technology transfer, process optimization, and process validation.

Located at Macquarie Park, Sydney and Reporting to the MS&T Leader, you will drive the development and optimisation of manufacturing processes for new and existing processes and products, ensuring robustness, scalability, and efficiency.

• Collaborate closely with cross-functional teams, including Research and Development, Engineering, Quality Assurance, and Regulatory Affairs, to support process improvements and technology advancements
• Utilise statistical tools and methodologies to analyse process data, identify areas for improvement, and implement appropriate solutions
• Lead the successful transfer of manufacturing processes from Engineering to commercial operations, ensuring seamless integration and adherence to regulatory requirements
• Establish and maintain effective relationships with internal and external stakeholders, and technology partners, to facilitate smooth technology transfer and knowledge exchange
• Drive a culture of continuous improvement, identifying opportunities for operational excellence, cost optimisation, and quality enhancement within manufacturing processes
• Stay abreast of emerging technologies, industry developments, and scientific advancements relevant to bio pharmaceutical manufacturing, and assess their potential applications for process improvement and innovation
• Champion the implementation of new technologies, process analytical tools, and digital solutions to enhance manufacturing capabilities and efficiency.

You will bring...

• Tertiary qualification in scientific discipline, such as pharmaceutical sciences, chemical engineering, biotechnology, or related fields
• Knowledge of cGMP regulations, FDA guidelines, and other relevant regulatory requirements
• Demonstrated expertise in process development, process validation, and manufacturing sciences
• Excellent problem-solving and decision-making skills
• Ability to prioritize and manage multiple projects simultaneously
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

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 ($110,000 -120,000 base salary) which includes an annual Bonus + the opportunity to join our Employee Share Option plan
• Close to public transport

Interested? Apply today...!!!!

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 Manufacturing QA Associate to join our Quality Assurance team. Reporting to Quality Assurance Manager, you will provide support in developing the company’s quality management system and assist peers with the daily running of the Quality Assurance Department.

What you will be involved in………

• Audit of production and QC documentation.

• Perform line clearance, pre and post production run.

• Support the QA Manager in the set-up and maintenance of QMS.

• Ensure QMS and operational compliance with regulatory requirements.

• Support for key QMS systems such as audits, CAPA, SOP review, etc.

• Support RA activities.

• Support in developing and implementing quality strategies.

• Deviation, NCR and complaint management, Products and Materials Release, Validation and Change Control Support, New production introduction and Documentation Controls to ensure an efficient operational Quality System that assures full compliance with company policies, regulatory requirements and cGMP.

• Responsible for ensuring that material supplied is fit for purpose for customer.

• Responsible for providing quality oversight for Operations activities.

• Support the QA Manager in continuous improvement projects and quality related improvement initiatives.

• Assist in internal audits and the review of validation reports.

• Issue and review batch documentation and release of batches of Intermediate, Bulk and Finished products.

What we would expect from you:

• Life Sciences (Chemistry, Microbiology, etc.) academic degree with experience in Pharmaceutical / Biopharmaceutical industry within Australia and Internationally.

• Experience in research and large-scale bioprocessing techniques.

• An understanding and experience of quality systems and the need to develop and follow SOPs, particularly in a cGMP environment.

• Strong interpersonal and communication skills.

• Ability to grasp new concepts quickly and to assimilate data from a range of scientific ideas.

• Ability to work under pressure and to strict guidelines.

• Ability to manage time and to delegate as appropriate.

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...!!!!