Cell Therapies Production Manager

● Global leader in medical research, discovery and innovation

● part time or full time TAP 8 (0.6 FTE - 1.0 FTE)

About the Hudson Institute of Medical Research

A leading Australian biomedical research institute, Hudson Institute pioneers outstanding discovery science and translational research - we progress scientific knowledge into new diagnostics, treatments and cures

We are home to 470 world-class scientists and students who push the boundaries of scientific knowledge to progress human health in three areas of medical need cancer, inflammation and reproduction and child development.

Together with our onsite precinct partners, Monash Health and Monash University, we deliver outstanding healthcare, education and world-class research. Working alongside clinicians, who often join our research teams, ensures our research is informed by clinical challenges faced by our site and optimally positioned for development.

Co-located within the Institute, and shared with our partners, are nine state-of-the-art Technology Platforms and a Clinical Trials Facility, providing the optimum environment for scientists, clinicians and our collaborators to move breakthrough discoveries to patient care.

The Institute has an active program for the patenting and commercialisation of technologies, including those developed in conjunction with academic and commercial collaborators.

We nurture and inspire the next generation of scientists and clinicians by educating and training more than 180 students each year, predominately through our academic affiliation with Monash University.

We have worked alongside clinicians in Melbourne hospitals for more than 50 years, our rich history of breakthroughs has included discovering that embryonic stem cells develop into new cells in the body - the foundation of modern stem cell treatments; changes in practice that have helped to prevent Sudden Infant Death Syndrome (SIDS) and the discovery of Inhibin which led to diagnostic tests for Down syndrome and some ovarian cancers.

About Hudson Cell Therapies

At Hudson Cell Therapies (HCT) we offer a core service in the compliant processing of minimally manipulated human blood and tissue products for early phase HREC approved investigator lead clinical trials with TGA CTN notifications. In addition, HCT currently holds conditional ISO 15189 accreditation to provide cryopreservation, storage & distribution services to Monash Health’s Cell Therapy Program in support of their autologous stem cell transplantation standard of care. Work undertaken by HCT does so within our Quality Management framework, ensuring consistent accountability, risk assessment and reproducibility while providing clients with confidence in their results.

Overview of Position

We are looking for an experienced HPC processing and cryopreservation scientist, familiar with the NPAAC and NATA 15189 standards as well as clinical workflows, to take our production capabilities forward. This is an opportunity for the right candidate to become part of a small, dedicated and dynamic team charged with establishing and growing a robust production service to provide for local precinct stakeholders and beyond.

Position Environment

The position is a direct report of the Hudson Institute Chief Operating Officer and will work closely with the service Medical director as well as Quality Management, Precinct Facilities Management and Production Support Operators. The Production Manager would be a primary adviser to Hudson Cell Therapies, and external stakeholders, in relation to therapeutic goods production within the cell therapy facility.

Skills & Experience

· Minimum 5 years hands-on experience performing HPC processing and cryopreservation activities with management responsibilities within an ISO 15189 accredited laboratory.

· Experience training staff with competency oversight of Production team.

· Ability to interpret and apply relevant regulations to maintain product safety and quality above all.

· Experience contributing to, and working within, accredited Quality Management Systems; experience with electronic QMS highly desired.

· Previous experience within scientific service provision role, including client facing responsibilities.

· Membership of affiliated professional bodies with participation in local conferences & workshops desired.

· Demonstrable, exemplary, written and verbal communication skills.

· Ability to operate with high degree of independence.

· Ability to adopt client-facing responsibilities within service providing environment.

· Ability to develop and deploy training protocols.

Typical Responsibilities

· Develop, deploy and maintain an efficient, compliant and standardised production service that meets and exceeds NPAAC & ISO 15189 standards.

· Manage & execute day to day operations of the facility that support production capabilities.

· Contribute to a culture of continuous improvement within HCT that aligns with established precinct operations and business practices as well as stakeholder expectations.

· Contribute to leadership and strategic direction of HCT by drawing upon recognised and relevant experience.

· Manage and cultivate staff performance and professional development.

· Monitor human and material resources required to maintain robust production services.

· Manage and maintain critical equipment, including where appropriate, design and execution of validation protocols and maintenance procedures; utilising external service providers when required.

· Report and communicate issues, present and emerging, that impact production safety or service, contribute to risk mitigation strategies.

· Develop and implement production service budgeting and operations reporting practices.

· Partake in and contribute to HCT internal training and development programs, in compliance with relevant standards and demands.

Applications open until 5pm Tuesday 14 May 2024 - Only shortlisted candidates will be contacted for interview. Enquiries HR@Hudson.org.au  

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 (and Monash Health) mandatory vaccination mandates apply to all Hudson employees. As part of the application process, evidence of an immunisation history statement or COVID -19 Digital Certificate is required. No offers of employment will be made without the appropriate evidence being provided.

Hudson Institute of Medical Research

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.

Source: This extract was provided by the company.

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.

Source: This extract was provided by the company.

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