cGMP Technician Upstream & Downstream - Multiple Positions - [Archived Advertisement]
cGMP Technician Upstream & Downstream - Multiple Positions
- Work on the production of biologics for clinical trials
- cGMP Upstream and Downstream Technician roles available
- Work with leading international researchers in a flexible work environment
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 several current Good Manufacturing Practice (cGMP) Technicians (Upstream & Downstream) to work at CSIRO’s new cGMP pilot scale facility?in?the production of biologics for clinical trials (Phase I and beyond). Our clients will include Australian and overseas researchers, biotech and biopharmaceutical organisations, supporting the development of new biologics and growing the biotech industry.?The?cGMP Technicians work?will include upstream processing (media and reagent preparations, cell culture, scaling up to stirred tank bioreactors, filtration), downstream processing (chromatography, viral reduction, tangential flow filtration), and/or fill and finish.?
This is a fantastic opportunity to work on projects of global significance in our brand-new world class Advanced Biologics Manufacturing Facility.
Applications are invited across two capability levels and the successful candidate will be appointed at the level commensurate with their skills and experience. More detail around the difference between the two levels is outlined in the PD.
Your duties will include:
- Participating in manufacturing activities to meet production schedules,?which?will require weekend work.?
- Performing upstream or downstream processing activities in clean room conditions.?
- Adhering to the requirements of the Quality Management System (QMS) and Pharmaceutical Quality System (PQS).??
- Accurate and timely completion of quality records, review quality and process documents under the QMS/PQS.?
- Identify and report quality events in a timely manner according to procedure. Participate in investigations related to quality events (OOS, deviations, non-conformance).??
- Participation in process reviews, CAPA and risk assessments, contribute to audits by clients or regulatory bodies.
- Contributing to the maintenance of the facility (cleaning and technical sanitisation, environmental monitoring, ordering). Assist in the commissioning, validation and re-validation of equipment.?
- Undertaking experiments, laboratory analyses or technology development activities (some non-routine) using a range of techniques, often working on a?numerous?parallel and competing tasks.??
- Additional duties are required for appointment to the higher level as outlined in the PD.
Location: Clayton, VIC
Salary: AU$64k - AU$96k plus up to 15.4% superannuation
To be considered you will need:
- Relevant bachelor’s degree or equivalent relevant work experience in?Cell Biology, Biotechnology, Biochemistry, Chemical Engineering or Process Engineering.?
- Extensive experience?with?sterile techniques.?
- A current Australian driver’s licence.?
- Computer literacy and familiarity with MS Office applications.?
- Track record of working collaboratively within a team to achieve results.?
- Ability to use judgement to select the best option for improving performance (better yields, higher quality, improved client satisfaction).?
- Experience in cGMP manufacture of biologics, working in and maintaining clean rooms, and experience with viral clearance techniques is advantageous.
- Experience with filling out Quality Records suitable for cGMP manufacture would be highly regarded.
- Experience in recombinant protein production in mammalian cells at bench scale and industrial bioreactor scale, automated?chromatography systems and/or fill and finish is desirable.
- Additional criteria listed in the position description to be appointed at the higher level.
For full details about this role please review the Position Description
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.
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.
12 August 2021, 11:00pm AEST
- Closing Date:
- 12 Aug 2021
- VIC - Clayton
- AU$64k - AU$96k plus up to 15.4% superannuation
- Work Type:
- Full Time