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Quality Control Manager

Date: 15-Jul-2021

Location: Melbourne, VIC, AU

Company: CSIRO

The Opportunity

 

  • Work on vaccine and biotherapeutic research of national and global significance 
  • World class facilities and state of the art manufacturing technology 
  • Flexible work arrangements! Mix of home and office 

 

CSIRO’s Manufacturing Business Unit provides multi-disciplinary scientific and engineering capabilities using world-class infrastructure to deliver innovative solutions for our clients, including 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 Manager to lead testing to support GMP manufacture of vaccine and biotherapeutic candidates for use in preclinical and early human clinical (Phase I and Phase II) studies.  Reporting to the Protein Production Lead, you will bring advanced knowledge of analytical test methodologies to support the development of new human biologic products. This exciting opportunity allows you to work on projects of global significance in our brand-new world class Advanced Biologics Manufacturing Facility. 

Your duties will include:

 

  • Leadership of all aspects of Quality Control for testing of biological products including physiochemical, biological, microbiological, and compendial techniques.  
  • Serving as the point of accountability for development, qualification, validation, and transfer of new methods into the GMP testing laboratory, including writing analytical validation protocols and reports for transfer of both drug substance and drug testing methods with potential weekend work.  
  • Implement and maintain a LIMS for sample tracking and data recording within a GMP environment.  Data consolidation, analysis, and reporting to support continuous improvement initiatives.  
  • Assuming ownership of testing equipment and maintain the same equipment in a GMP-ready state.  Work in partnership with the CSIRO QA Lead to maintain the testing laboratory in a state of cGMP and maintain a state of compliance and audit-readiness in all Analytical laboratory functions.   
  • Using expert knowledge of biological testing requirements to generate specifications for GMP manufacture in accord with Preclinical and Phase I project requirements.    
  • Engaging with clients as an authority on all matters related to the Quality Control in the CSIRO GMP program.  Act as a trusted advisor, utilising knowledge of client’s business and understanding of their underlying needs.  Contribute to the planning of QC components in new project proposals.   
  • Participating in project scoping and planning activities that shape the future direction of the Quality Control function. Anticipating industry and/or community needs and market direction through client liaison/networking, to identify and adapt quickly to changes.   

 

Location: Clayton, VIC

Salary: AU$115k - AU$135k plus up to 15.4% superannuation

Tenure: Indefinite

Reference: 75942

To be considered you will need:

 

  • A relevant degree in fields of Chemistry, Biochemistry, or related field.  
  • Proven industrial experience in the development of analytical methods for characterisation and quantification of recombinant proteins, antigens and other biologics for regulated markets.  
  • Experience is writing Standard Operating Procedures. 
  •  Knowledge of the design and management of Quality Control frameworks for testing of new biotherapies including validation and transfer into GMP operations.    
  • Experience and knowledge of the GMP frameworks for manufacture and testing of vaccines and biotherapeutics with global regulators such as the TGA, US Food and Drug Administration, or European Medicines Authority is advantageous.  
  • Experience in managing a QC laboratory would be desirable. 
  • Experience in setting up and maintaining a Laboratory Information Management System (LIMS) for sample tracking would be highly regarded. 

 

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