GMP Downstream Processing Lead - [Archived Advertisement]
GMP Downstream Processing Lead
- 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
- Enable Australian researchers (academic and industrial) to take their Biologics lead to clinical trial
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 in partnership with Australian researchers for Phase-I and Phase-II clinical 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. We are focussed on growing local Med-Tech industry while improving Health outcomes.
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 isolation and purification) operations for manufacture of biotherapeutic proteins and vaccines within a GMP setting. Reporting to the GMP Team Leader, the Downstream Processing Lead will work closely with clients and internal research teams to develop the purification process then transfer the process to the GMP facility. They will draft process documentation and lead the GMP Downstream Processing effort, ensuring Biologics are produced safely and by industry-relevant methods.
Your duties will include:
- Providing 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.
- 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$135k plus up to 15.4% superannuation
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
The successful applicant will be required to obtain and provide a National Police Check or equivalent.
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.
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.
This role will remain open until filled, we encourage you to apply early to avoid missing out on the opportunity.
- Closing Date:
- 15 Oct 2021
- VIC - Clayton
- AU$100k - AU$135k plus up to 15.4% superannuation
- Work Type:
- Full Time