Subsequently, Mr. Ross successfully commissioned and validated a Speciality Chemicals Plant at Tasmanian Alkaloids before moving to the mainland to take up a Project Management position at CSL Bioplasma.
Mr. Ross’s initial position was with the Capacity Development Group where he was responsible for the investigation of various scenarios associated with plant capacity expansion including detailed strategies, costings and timelines.
Mr. Ross then took on the position of Lead Engineer on the Hemostatic Dressing Project Team which was contracted by the United States Army and the American Red Cross (ARC) to develop the aseptic production of a novel mass trauma hemostatic device from lab-scale process to high throughput production.
Upon the successful completion of the Battlefield Hemostatic Dressing Program Mr. Ross was seconded to Switzerland to instigate the Phase III and commercial aspects of the program.
At the completion of the Hemostatic Dressing project Mr. Ross returned to Australia to take up the CSL position of Project Manager (Medical & Research). His projects included the close out of several TGA GMP audit items associated with freeze driers, CFR 21 part 11, and general production issues. Other projects included the development of registered products to support current marketing strategies.
In 2004 Mr. Ross left CSL to gain experience in the design and operations of bio-containment facilities. In this position, Mr. Ross project managed a number of facility design and upgrade projects involving PC2 to PC4 containment.
Mr. Ross joined Business Biotics Group in 2006.
Mr. Ross’s Curriculum Vitae is available upon request.
Article: Mr. Paul Malouf, Company Director
Director, Mr. Paul Malouf has more than 30 years experience in the pharmaceutical and biotechnology industries.
Mr. Malouf began his career as an R&D scientist developing novel in-vitro (EIA) testing technology including the establishment of the first large scale monoclonal antibody facility in Australia. Subsequently he progressed from R&D into production management of large scale dispensing and packaging operations. In the early 1990’s, Mr. Malouf was the principal designer of the sterile filling and packaging operations of the CSL Bioplasma Blood fractionation facility located in Broadmeadows, Australia. This facility remains state-of-the-art and has set many benchmarks for future generations of pharmaceutical production facilities.
His association with CSL continued though the management of the start up, commissioning, validation and production activities in the dispensing and packaging areas of the Bioplasma facility.
Mr. Malouf’s most recent career activities included the management of the production of a novel haemostatic device designed to arrest life threatening haemorrhage. This project involved a collaborative effort between the US Military, American Red Cross and CSL. The engineering design and production process managed by Mr. Malouf was subsequently approved by the US FDA for Phase I/II clinical trial under an Investigative New Drug application. Mr. Malouf was directly responsible for ensuring that the production process, equipment and dispensing environment all conformed to the required FDA standards for production of aseptic clinical trial material.
Upon leaving CSL in July 2004, Mr. Malouf established Malouf Pharmaceutical Services Pty Ltd (MPS). MPS offered specialised aseptic processing consultancy services to the pharma/biotech industries.
Mr. Malouf is also a member of the BioGeelong Steering Committee. BioGeelong is an initiative of the City of Greater Geelong and is an industry based organisation that has been formed to assist in growing the Geelong Region's biotech capability and to maximise the opportunities being generated by Geelong's world-class biotech activities.
Mr. Malouf’s Curriculum Vitae is available upon request. 
|
