CGMP Production Co-ordinator - [Archived Advertisement]

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