Virbac manufactures implants that provide controlled release of an active substance that acts like the natural hormone gonadotropin-releasing hormone (GnRH) to render male dogs and ferrets temporarily infertile. I successfully manage a team responsible for the validation of all processes, equipment and analytical test methods, the execution of QC raw material and final product testing schedules and troubleshooting activities related to product improvement and raw material variability. I also manage the transfer of manufacturing and test methods across sites and external laboratories.

Genea Biomedx is a business unit within Genea, supplying medium and instrumentation for the process of In Vitro Fertilisation (IVF) to internal and independent clinics throughout Australia. My achievements to date as QC Manager include a reduction in QC costs by developing in-house tests and optimising existing test procedures.The QC team have established an off-site microbiological laboratory for the testing of environmental monitoring samples for our aseptic manufacturing facility. This contributed to further cost savings. Additional activities include process improvements in manufacturing procedures.

Clinical Genomics is a Sydney-based biotechnology company developing next-generation products for the diagnosis of colorectal cancers. My responsibilities include the overseeing and continuous improvement of the ColoVantage Home faecal immunochemical test (FIT) from the application of antibodies to a lateral flow test strip, substrate materials and processes for sample collection and gold conjugates. I was also responsible for the validation of processes, equipment and raw materials and the associated documentation.

Innovative Purification Technologies has developed two complementary technology platforms, novel affinity matrices for purification of therapeutic and diagnostic proteins and self assembling protein nano-particles (PNPs). My position involved the development and manufacture of these matrices, the setting up amd implementing of a quality system, management of a laboratory and performing some contract research.Major achievements during this time included:•Development of four ion-exchange resins using novel chemistries that exceeded the specifications of the current market leader for these products.•Developed, optmised and scaled-up a chemical process for agarose bead modification. •Designed equipment and processes for the manufacture of an agarose bead with superior strength and porosity than currently available.•Set up a quality system, drafted all documents (SOP's, Batch and Chemical Registers, Non-Conformance etc) for the company including WHS policies. Accreditation was subsequently achieved for both ISO 9001:2000 and ISO 14001:2004 (Environmental Management).•Developed a range of hydrogels as part of a contract research agreement for use in endovascular devices.

RPO’s technology provides the key components of a highly differentiated optical touch technology to the touch-screen market. My position involved stabilising the lab-scale production of IPG resin and then design and facilitate the construction of a scaled-up manufacturing facility. Major achievements during this time included:•Introduced the use of statistical process control in order to stabilise the lab-scale production of IPG resin used to manufacture waveguides. This reduced the variability in viscosity (a key parameter) from 20 to 10%.•Implemented an automated feedback control system for resin production. This further reduced variability to 5% with an increase in the amount of information gathered from the process for further statistical process control.•Commissioned contractors to fabricate equipment, and build a manufacturing area for the production of 12000 L/yr (lab-scale capacity was approx. 400L/yr). This included the design and installation of a Class 5 cleanroom with resin filtration and packaging.The company went into receivership at the beginning of April.

Silverbrook Research is a developer of various technologies in the area of printing intended for sale, which are rigorously protected by patents and confidentiality agreements. I worked in both the fluidics design and ink development teams. Achievements included:•Validation and verification of instrumentation for the quantification of contaminants in ink. This prevented the use of fluids in the print system that could significantly reduce the life of the product. It also aided in the verification of cleaning and assembly processes. •Design and commissioning of an ink production process for the manufacture of 100L/batch (previously 50mL) including pumps, stirrers and filtration devices. •Developed a test method for the characterisation of ink delivery systems. This aided in the design of effective spring components that ensured constant pressure with fluid flow.

Ambri was a start-up biotechnology company working on a disposable biosensor made by a molecular self-assembly process and the attachment of various biological ligands. I was responsible for the identification and minimising of variables into the process and the introduction of new equipment. Achievements included:•Reduction in variation of key measurement parameters from 12 to 5% by optimising the performance of fluid dispensing systems. •Increased the yield of manufactured sensors from 65 to 85% by the use of continuous improvement principles and experimental design.•Validated the use of a piezo-electric dispensing device for the assembly of the biosensor in a new format.

Gradipore is a life science company with activities in both Australia and the United States focused on biological separations at both the lab and industrial scale, proteomics and medical diagnostics. My responsibilities were in the development of new electrophoresis gel products, membranes for electrophoretic separations and the scaling up of the Gradiflow technology for use in blood fractionation. Achievements included:•Increased the manufacturing capacity of electrophoresis gels by a factor of 12x by the introduction of new manufacturing design and equipment. •Reduced the failure rate of gels from 60 to 10% by the design and introduction of a new cassette design.•Reduced the variability in polyacrylamide membrane pore size so that the overall pass rate was increased to 97% from 45 – 55%. This was done by a change in manufacturing method and formulation optimising. •Successful collaborations with the University of Melbourne (the development of polyacrylamide products and troubleshooting programs) and Dolphin Products (moulded housings for electrophoresis gels and membranes).

CSR is a large multinational company with operations in construction materials as well as sugar and its by-products. My roles were focused on the extraction and use of tannin from pine bark for the use in composite wood products.Achievements Included:•Organised the trialling the extracted tannin on the manufacturing line. This involved the production of sufficient extracted material, scheduling time on the factory line and adjusting the proportion of cross-linking material as indicated from laboratory tests. Composite board properties from these trials were eventually equivalent to the existing system. •Developed resin formulations for the unique properties of the extracted tannin compared with the existing resin system. •As part of a centralised R&D group, developed test methods for a range of timber products including moulded door-skins, MDF and the painting/laminating of these products.