Quality Control Scientist - [Archived Advertisement]

The Opportunity

• Quality control of vaccine and biotherapeutic research of national and global significance 
• World class facilities and state of the art manufacturing technology 
• Diverse and inclusive culture. Flexible work arrangements! 

CSIRO’s Manufacturing Business Unit provides multi-disciplinary scientific and engineering capabilities using world-class infrastructure to deliver innovative solutions for our clients. This includes new products, components and materials that allow Australian manufacturers to be globally competitive and environmentally sustainable. 

Our Biomedical Manufacturing team requires a current Good Manufacturing Practice (cGMP) Quality Control Scientist to provide support in the field of Quality Control (QC) testing to for GMP manufacture of vaccine and biotherapeutic candidates for use in preclinical and early human clinical (Phase I and II) studies.? The position reports to the Protein Production Lead and will bring knowledge of analytical test methodologies to support the development of new human biologic products.? 

Be part of an expert team working on research of global significance and using state of the art technologies and facilities. 

Your duties will include:

• Supporting in all aspects of Quality Control for testing of biological products including physiochemical, biological, microbiological, and compendial techniques including weekend work.
• Working on programs that enable qualification, validation, and transfer of new methods into the GMP testing laboratory. This includes writing sections of analytical validation protocols and reports for transfer of both drug substance and drug testing methods.
• Supporting the implementation and maintenance of a LIMS for sample tracking and data recording within a GMP environment.
• Assuming ownership of testing equipment and maintaining equipment in a GMP-ready state. Working in partnership with the supervisory staff to maintain the testing laboratory in a state of cGMP compliance and audit-readiness. 
• Engaging with internal partners as an expert in selected analytical methods as they pertain to the analysis and testing of new vaccines and recombinant proteins.

Location: Clayton, VIC
Salary: AU$85k - AU96k plus up to 15.4% superannuation
Tenure: Indefinite
Reference: 75981

To be considered you will need:

• A relevant degree in Analytical Chemistry, Biochemistry, Microbiology or related field.
• Industrial experience (ideally 2-5 years) in the development of analytical methods for characterisation and quantification of recombinant proteins and antigens for regulated markets. 
• Working knowledge of the requirements for assay qualification, validation, and transfer within a GMP framework would be advantageous, as would direct experience and working knowledge of the GMP frameworks for manufacture of vaccines and biotherapeutics with global regulators such as the TGA, US Food and Drug Administration, or European Medicines Authority.
• Experience in sample tracking through a Laboratory Information System?(LIMS)?is also desirable 

For full details about this role please review the Position Description

Eligibility

To be eligible to work in CSIRO you must be an Australian Citizen, Permanent Resident or either hold, or be able to obtain, a valid working visa.

The successful applicant will be required to obtain and provide a National Police Check or equivalent. Additional integrity checks may be required for specific roles which require security clearance for working with children, Australian Government cybersecurity requirements or other identified security roles.

Flexible Working Arrangements

We work flexibly at CSIRO, offering a range of options for how, when and where you work. 

Diversity and Inclusion

We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish. 

About CSIRO

At CSIRO Australia's national science agency, we solve the greatest challenges through innovative science and technology. We put the safety and wellbeing of our people above all else and earn trust everywhere because we only deal in facts. We collaborate widely and generously and deliver solutions with real impact. 

Join us and start creating tomorrow today!

How to Apply

Please apply on-line and provide a cover letter and CV that best demonstrate your motivation and ability to meet the requirements of this role.

Applications Close

12 August 2021, 11:00pm AEST