POSITION DESCRIPTION Title: Group & Centre: Employment Agreement Classification MHTP Cell Therapies Platform Manager (Fixed Term) Support Services Group Hudson Institute of Medical Research Enterprise Agreement 2015 TAP 7 TAP 8 depending on qualifications / experience Date Last Updated: May 2016 1. About Hudson Institute The Hudson Institute is a premier Australian discovery and translation medical research institute. By unravelling the biology underlying disease the Institute will use this information for transformative and innovative solutions to major health problems. The Hudson Institute has diverse strengths and research excellence encompassing paediatric and perinatal medicine, cancers, infectious and inflammatory diseases, endocrinology and reproductive health. Progressing our research requires a focused and directed strategy that incorporates thematic and programmatic excellence across the Institute. The Institute Centres will coordinate their research activity to take advantage of novel approaches and new models of disease. Enabling technologies will be shared and new platforms developed to meet new research challenges. As the major research partner at the Monash Health Translation Precinct (MHTP) the Institute will underpin the research agenda of the precinct and drive research solutions to disease, leading to better health outcomes. Sophisticated cutting edge technologies co-located with clinical and laboratory research activities in the Translational Research Facility of the MHTP will enable the rapid translation of breakthrough discoveries to clinical care. Clinicians bring problems they have encountered at the bedside back to the laboratories to find solutions that will enhance patient s lives. The co-location of the Institute with Monash Health one of the largest health care organizations in Australia, and our partnership with Monash University, the largest tertiary education and research organisation in Australia, enables the focus to be on patient needs. The research undertaken by the Hudson Institute will address the major burdens of disease identified as priorities by the Federal Government and National Health and Medical Research Council and will integrate its research priorities with the themes of Monash Partners, a NHMRC accredited Advanced Health Research and Translation Centre. The Hudson Institute will be integral to the Faculty of Medicine Nursing and Health Sciences (FMNHS) external relations strategic plan promoting strong relationships with hospital partners, driving interdisciplinary research in areas of national and global need and leveraging international partnerships. To enable the vision of the Hudson Institute to be world leading in research and translation we must ensure our financial security, develop and nuture a highly skilled workforce, reward excellence and fully engage with the community to share and celebrate our ground breaking achievements. 1
2. Overview of the Position The purpose of this position is to further develop and manage operations within the Cell Therapies Platform hosted which is hosted by the Monash Health Translation Precinct. The incumbent will also manage and promote the MHTP Cell Therapies Platform in its aims to facilitate research and clinical translation of cell therapies through the provision of GMP accredited facilities. The position will report to the MHTP Platforms Strategic Operations Manager and the Cell Therapies Scientific Director and will be fully integrated into the MHTP Technology Platform Network and the MHTP led Victorian Consortium for Cell-based Therapies (VCCT). The Cell Therapies Platform Manager will be responsible for the day-to-day management and operation of the Platform. The role will include: Key Responsibilities Operational management of Biological Isolator Facilities and associated Cell Therapy Platform capabilities Formal commissioning (i.e. Installation Qualification, Operational Qualification and Performance Qualification) of Cell Therapy Platform Equipment Coordination and oversight of equipment and facility maintenance activities e.g. scheduling of preventative maintenance, validation of equipment and processes, review of contractors, housekeeping Development and implementation of GMP training, competency assessments and support for MHTP and VCCT personnel, external clients and contractors wishing to use the facilities 3. Accountabilities, Characteristics and Responsibilities Area Training Level, Qualifications & Experience: Requirement Tertiary qualification in a Science or related discipline Minimum 5 years experience in managing the operations of a cell based manufacturing facility/laboratory Experience in the manufacture of biological therapeutics, preferably cell-based therapies, is highly desirable Supervision & Leadership Operational management of Biological Isolator Facilities and associated Cell Therapy Platform facilities Provide advice and guidance to clients on operational matters and process development activities, as required and as agreed to within contracts to be drawn up between the parties Management of access to isolators and associated equipment Experience in training and education of other staff Knowledge Formal commissioning (i.e. Installation Qualification, Operational Qualification and Performance Qualification) of Cell Therapy Platform Equipment Completion of the creation, review and 2
implementation of facilities and updating of policies and procedures Coordination and oversight of equipment and facility maintenance activities e.g. scheduling of preventative maintenance, validation of equipment and processes, review of contractors, housekeeping Development and implementation of GMP training and competency assessments for MHTP and VCCT personnel, external clients and contractors wishing to use the facilities Implementation of material management procedures. Control of materials as appropriate for their intended use (research vs clinical use) Implementation of policies and procedures to ensure compliance of facilities and users with cgmp guidelines, OH&S regulations, and OGTR (as applicable) Identify issues and management of risks associated with the operation of the facilities Communication & Profile Liaison with key MHTP personnel on facility matters (e.g. engineering services) Assist with the management of contracts between clients and with service providers Coordinate and assist with reporting obligations for Funding Agreements, as applicable Promote the MHTP Cell Therapies Platform through PR, networking and participation at academic and industry events Contribute to applications for funding of Cell Therapies operations and activities Judgment, Innovation and Problem Solving Assist in and advise on the ongoing development of the MHTP Cell Therapies Platform Excellent interpersonal skills and effective verbal and written communication Successful problem solving and analytical skills Project management skills Experience in achieving results through prioritisation, organisation and time management Demonstrated ability to exercise a high degree of responsibility, independent decision-making and relationship management. 4. Working Relationships Internal Supervisor Administrative Staff Laboratory Head Laboratory Staff Scientific Support staff 3
5. About the Hudson Institute Vision and Values: Our Vision: We strive to enhance human health and the quality of life through groundbreaking, collaborative, medical research discoveries and innovation, and ensure its direct impact on the community. Our Mission: To capitalise on our multidisciplinary research strengths and academic and health partnerships to provide transformative and innovative solutions to major health problems. Our Values: Innovation: We inspire and enable world class researchers at the frontiers of science and medicine to find new and transformative solutions to people s greatest health challenges. Collaboration: Our multidisciplinary, integrated approach creates an enriched, energetic environment that encompasses the entire lifespan; this allows our researchers and clinicians to leverage each other s knowledge to spark creative ideas and make unexpected discoveries. Community: Excellence: We care deeply about improving the health and wellbeing of people in the community and we are committed to rewarding their investment in science. Integrity and passion underpin our pursuit of the highest level of knowledge achieving significant outcomes whilst nurturing and inspiring the next generation of scientists. Other relevant information: The Hudson Institute is a totally smoke free workplace. The position is subject to terms set out in the Hudson Institute Enterprise Agreement (2015), Policies and Procedures and any subsequent variation to these. The Hudson Institute is an Equal Employment Opportunity Employer. The Hudson Institute has a commitment to Occupational Health and Safety. It is a condition of employment that staff comply with all health and safety related policy and procedures and take part in activities designed to improve the health and safety of the workplace. It is a requirement of the position to participate in the annual Performance Planning and Review process. It is a requirement of the position to participate in the annual Performance Planning and Review process. 6. Endorsement Name: (Supervisor) Name: (Employee) 4
Name: (HR) 5