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CSIRO’s Manufacturing Business Unit brings together multi-disciplinary scientific and engineering capabilities using world-class infrastructure to partner with industry in order to develop innovative products and processes to allow Australian manufacturers to be globally competitive and environmentally sustainable. The Biomedical Manufacturing Research Program works with biomedical companies to deliver new medical treatments and technologies that benefit millions of people in Australia and overseas, helping them live longer, healthier, and more productive lives. This role will be a part of CSIRO’s Regulated Biomanufacturing, Quality Operations team playing a vital role in providing advanced scientific leadership in solving complex problems across a wide range of projects.
Job Responsibility:
Testing of biological products including physiochemical, biological, protein chemistry, and compendial techniques
Developing, transferring, verifying, and qualifying new methods into the CSIRO Biologics Quality Control laboratory, including hands-on leadership of experimental development programs, writing protocols, and reports for qualification of novel or transferred protocols
Leading strategic initiatives and facilitating the development/ implementation of new technologies that streamline analytical development, improve throughput, or enhance the quality of services provided to our customers
Evaluating new analytical technologies and determining the feasibility/fit/value delivered to CSIRO Analytical development projects
Utilising expert knowledge of biological testing requirements and generating phase appropriate specifications and stability programs to support cGMP manufacture following Preclinical, Phase I, and Phase II project requirements
Acting as a trusted advisor to the client by utilising knowledge of the client’s business practice and understanding of their underlying needs
Partnering with the CSIRO QA Lead and maintaining the testing laboratory in a state of cGMP compliance and audit-readiness in assigned Analytical laboratory functions
Requirements:
A relevant degree or equivalent experience in Chemistry, Biochemistry, or related fields
Comprehensive industry experience in developing complex analytical methods for the characterisation and quantification of recombinant proteins and antigens for regulated markets
Expert knowledge of the design and management of Quality Control frameworks for testing of new biotherapies including validation and transfer into GMP operations
Technical expertise and hands-on experience with state-of-the-art LCMS and other instrumentation used in the characterisation of proteins and biologics
Experience in leading staff on projects, including setting up effective and efficient teams
Extensive experience influencing third parties through communication to gain support for potentially contentious proposals
What we offer:
Supportive, rewarding, inclusive and truly flexible environment
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