GMP Downstream Processing Lead - [Archived Advertisement]

The Opportunity

• Technical leadership of protein isolation and purification operations for manufacture of biotherapeutic proteins and vaccines 
• Work at CSIRO’s new world class Advanced Biologics Manufacturing Facility 
• Facilitate production of vaccine & drug candidates of national and global significance 

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) Downstream Lead to provide hands-on technical leadership in the field of Downstream Processing (protein and other biologics capture and purification) operations for manufacture of biotherapeutic proteins and vaccines within a GMP setting.? The position reports to the?Team?Leader?of GMP and is responsible for provision of advanced knowledge in the discipline of industrial scale protein chemistry.? The role plays a key function in facilitating transfer of new protocols for biotherapeutic protein isolation and purification into the GMP laboratory, often working closely with the Research Protein Purification scientists.? 

Your duties will include:

• Provide hands-on leadership of Downstream Processing activities in a GMP setting and serve as a point of accountability for transfer and implementation of new manufacturing methods, which will require 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 downstream processing data to identify opportunities for continuous improvement in the operation of bioprocessing systems.????? 
• Assuming ownership of downstream bioprocess equipment and maintain the same equipment in a?GMP-ready state.?? 
• Accurately write and review?of 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?protocols for industrial scale protein purification.???Acting 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: 75941

To be considered you will need:

• A degree in Biochemistry, Biotechnology, Biochemical Engineering, or related field.? 
• Comprehensive industrial experience in?downstream process development for?manufacture of biotherapeutic proteins and vaccines for regulated markets.? 
• Theoretical and practical knowledge of unit operations for protein isolation and purification including chromatography (multiple modes),?virus inactivation and filtration,?normal and tangential flow filtration, and buffer exchange.??The scope of experience shall include process development, optimisation, transfer, and troubleshooting.? 
• Extensive experience working under the framework for Good Manufacturing Practices (GMP) gained through industrial experience.? 
• Experience in design and qualification of unit operations for virus removal and inactivation using orthogonal approaches, virus inactivation (by chemical or pH treatment) and removal by filtration, or experience in the design and execution of virus spiking studies for process qualification will be highly regarded.??? 
• Direct experience and working 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?would also 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