You are applying for the position of Cell Therapies Production Manager for Hudson Institute of Medical Research .Please fill in your details below to submit an application for this position. The primary site for this position is: Melbourne About the Hudson Institute of MedicalResearch Together with our onsite precinct partners, MonashHealth and Monash University, we deliver outstanding healthcare, education andworld-class research. Working alongside clinicians, who often join our researchteams, ensures our research is informed by clinical challenges faced by oursite and optimally positioned for development. Co-located within the Institute, and shared withour partners, are nine state-of-the-art Technology Platforms and a ClinicalTrials Facility, providing the optimum environment for scientists, cliniciansand our collaborators to move breakthrough discoveries to patient care. The Institute has an active program for thepatenting and commercialisation of technologies, including those developed inconjunction with academic and commercial collaborators. We nurture and inspire the next generation ofscientists and clinicians by educating and training more than 180 students eachyear, predominately through our academic affiliation with Monash University. We have worked alongside clinicians in Melbournehospitals for more than 50 years, our rich history of breakthroughs hasincluded discovering that embryonic stem cells develop into new cells in thebody - the foundation of modern stem cell treatments; changes in practice thathave helped to prevent Sudden Infant Death Syndrome (SIDS) and the discovery ofInhibin which led to diagnostic tests for Down syndrome and some ovariancancers. About Hudson Cell Therapies AtHudson Cell Therapies (HCT) we offer a core service in the compliant processingof minimally manipulated human blood and tissue products for early phase HRECapproved investigator lead clinical trials with TGA CTN notifications. Inaddition, HCT currently holds conditional ISO 15189 accreditation to providecryopreservation, storage & distribution services to Monash Health's CellTherapy Program in support of their autologous stem cell transplantationstandard of care. Work undertaken by HCT does so within our Quality Managementframework, ensuring consistent accountability, risk assessment andreproducibility while providing clients with confidence in their results. Overview of Position We are looking for an experienced HPC processing andcryopreservation scientist, familiar with the NPAAC and NATA 15189 standards aswell as clinical workflows, to take our production capabilities forward. Thisis an opportunity for the right candidate to become part of a small, dedicatedand dynamic team charged with establishing and growing a robust productionservice to provide for local precinct stakeholders and beyond. Position Environment The position is a direct report of the HudsonInstitute Chief Operating Officer and will work closely with the serviceMedical director as well as Quality Management, Precinct Facilities Managementand Production Support Operators. The Production Manager would be a primaryadviser to Hudson Cell Therapies, and external stakeholders, in relation totherapeutic goods production within the cell therapy facility. Skills & Experience · Minimum 5 years hands-on experience performing HPCprocessing and cryopreservation activities with management responsibilitieswithin an ISO 15189 accredited laboratory. · Experience training staff with competency oversightof Production team. · Ability to interpret and apply relevant regulationsto maintain product safety and quality above all. · Experience contributing to, and working within,accredited Quality Management Systems; experience with electronic QMS highlydesired. · Previous experience within scientific serviceprovision role, including client facing responsibilities. · Membership of affiliated professional bodies withparticipation in local conferences & workshops desired. · Demonstrable, exemplary, written and verbalcommunication skills. · Ability to operate with high degree of independence. · Ability to adopt client-facing responsibilitieswithin service providing environment. · Ability to develop and deploy training protocols. Typical Responsibilities · Develop,deploy and maintain an efficient, compliant and standardised production servicethat meets and exceeds NPAAC & ISO 15189 standards. · Manage& execute day to day operations of the facility that support productioncapabilities. · Contributeto a culture of continuous improvement within HCT that aligns with establishedprecinct operations and business practices as well as stakeholder expectations. · Contributeto leadership and strategic direction of HCT by drawing upon recognised andrelevant experience. · Manageand cultivate staff performance and professional development. · Monitorhuman and material resources required to maintain robust production services. · Manageand maintain critical equipment, including where appropriate, design andexecution of validation protocols and maintenance procedures; utilisingexternal service providers when required. · Reportand communicate issues, present and emerging, that impact production safety orservice, contribute to risk mitigation strategies. · Developand implement production service budgeting and operations reporting practices. · Partakein and contribute to HCT internal training and development programs, incompliance with relevant standards and demands. Applications open until 5pm Thursday 11 April 2024 - Only shortlisted candidates will be contacted for interview Enquiries - Hudson Institute is committed to empowering our people and harnessing their diversity to build an inclusive and equitable work environment. We encourage people of all abilities, Aboriginal and Torres Strait Islander people, members of the LGBTQIA+ community, diverse cultures and backgrounds, and all age groups to apply. As Hudson Institute is located within a Healthcare setting, the CHO (andMonash Health) mandatoryvaccinationmandatesapply toall Hudson employees. As part of the application process, evidence of animmunisation history statement or COVID -19 Digital Certificate is required. No offers of employment will be made without the appropriate evidence being provided. #J-18808-Ljbffr
