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GMP Upstream Lead

Date: 15-Jul-2021

Location: Melbourne, VIC, AU

Company: CSIRO

The Opportunity

 

  • Technical leadership of bioreactor operations for manufacture of biotherapeutic proteins and vaccines 
  • Facilitate the transfer of new bioreactor protocols into the GMP Laboratory 
  • Join our new high-tech Advanced Biologics Manufacturing Facility 

 

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. 

 

CSIRO’s Advanced Biologics Manufacturing Facility is currently being built and is expected to be open by the end of 2021. The facility will produce biologics for Phase-I and Phase-II trials to assist in the progression of biologics such as vaccine and drug candidates into safe and effective pharmaceuticals that can be manufactured at scale using industry-relevant techniques. 

 

Our Biomedical Manufacturing team requires a current Good Manufacturing Practice (cGMP) Upstream Lead to provide hands-on technical leadership in the field of Upstream (bioreactor) operations for manufacture of biotherapeutic proteins, vaccines and other biologics within a GMP setting.  The position reports to the GMP Team Leader and is responsible for provision of advanced knowledge in the discipline of bioreactor operations.  The role plays a key function in facilitating transfer of new bioreactor protocols into the GMP laboratory.  

Your duties will include:

 

  • Providing hands-on leadership of upstream cell culture activities in a GMP setting and serve as a point of accountability for transfer and implementation of upstream manufacturing methods including weekend work.  
  • Leading by expertise and influence to ensure that new manufacturing protocols are established in accord with the cGMP quality framework and are completed within the agree timeframes and budget.  
  • Generating and analysing upstream bioprocess data to identify opportunities for continuous improvement in the operation of bioprocess systems.      
  • Assuming ownership of upstream bioprocess equipment and maintain the same equipment in a GMP-ready state.   
  • Accurately write and review GMP batch manufacturing records.  Communicating research results to clients and the scientific community through oral and written reports, which may include the preparation of documents for patent applications.  
  • Engaging with clients as an authority on upstream cell culture methods.   Act as a trusted advisor, utilising knowledge of client’s business and understanding of their underlying needs.  

 

Location: Clayton, VIC

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

Tenure: Indefinite

Reference: 75901

To be considered you will need:

 

  • A degree in Biotechnology, Biochemical Engineering, or related field.  
  • Industrial experience in the development and application of cell culture methods for manufacture of biotherapeutic proteins and vaccines for regulated markets.  
  • Theoretical and practical knowledge of bioreactor unit operations including process development, optimisation, transfer, and troubleshooting.  
  • Extensive experience working under the framework for Good Manufacturing Practices (GMP) gained through industrial experience.  
  • A relevant advanced degree and experience 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 would be advantageous 

 

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