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CGMP Production Co-ordinator

Date: 15-Jul-2021

Location: Melbourne, VIC, AU

Company: CSIRO

The Opportunity

 

  • Lead GMP manufacturing of vaccine & biotherapeutic candidates 
  • Work at CSIRO’s high tech new Advanced Biologics Manufacturing Facility 
  • Flexible work arrangements! Achieve the right balance for you 

 

CSIRO’s Manufacturing Business Unit provides multi-disciplinary scientific and engineering capabilities using world-class infrastructure to deliver innovative solutions for our clients. This include 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) Production Coordinator to provide leadership in GMP manufacture of vaccine and biotherapeutic candidates for use in preclinical and early human clinical (Phase I and Phase II) studies.  The position reports to the GMP Team Leader and requires advanced knowledge of manufacturing technology to support the development of new human biologic products.   

  

This is a fantastic opportunity to work on projects of global significance in our brand-new world class Advanced Biologics Manufacturing Facility. 

Your duties will include:

 

  • Provide guidance, support, and leadership in all aspects of GMP manufacturing to enable activities in the CSIRO GMP facility and the CSIRO NCRIS GMP (APVMA/ISO) facility together with a supporting Quality Control laboratory.    
  • Create, maintain, and communicate a master schedule for manufacturing activities within both CSIRO GMP facilities.   
  • Work in partnership with Upstream and Downstream leads and Facility Manager to lead the construction of Bills of Materials (BOMs) and establish batch documentation for manufacture of new vaccines and therapeutic proteins including regular weekend work.   
  • Work in partnership with QC manager and QA manager to construct in process sampling plan and help to schedule QC testing.  
  • Provide expert facilitation of technology transfer of new manufacturing protocols into GMP operations.  Lead teams through risk assessment activities using industry-relevant tools such as Failure Mode Effects Analysis (FMEA) to ensure first-pass success in establishment of new manufacturing systems.    
  • Generate and analyse GMP process manufacturing parameters to identify opportunities for continuous improvement in operations.   
  • Engage with and advise clients on all matters related to GMP manufacture of vaccines and biotherapeutic candidates for early preclinical and clinical studies.    

 

Location:  Clayton, VIC

Salary: AU$100k - AU$108k plus up to 15.4% superannuation

Tenure: Indefinite

Reference: 75890

To be considered you will need:

 

  • A degree in Biotechnology, Biochemical Engineering, or related field.  
  • Comprehensive industrial experience in the development and manufacture of biotherapeutic proteins and vaccines for regulated markets.  
  • Extensive experience working under the framework for Good Manufacturing Practices (GMP) gained through industrial experience.  
  • Experience in project planning and management in the industry for development and GMP manufacture of vaccines and biotherapeutics, including the use of project or planning software is desirable.   
  • A track record in the application of risk management tools and principles (eg: ICH Q8, Q9, and Q10 and FMEA) to support transfer of new manufacturing processes into GMP operations would be advantageous.  
  • Experience and knowledge of the GMP frameworks for manufacture of human vaccines and biotherapeutics with global regulators such as the TGA, US Food and Drug Administration, or European Medicines Authority 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