Careers

GMP Facility Manager

Cell Therapies is seeking a GMP Facility Manager to join its leadership team, reporting to the CEO and CSO. Cell Therapies Pty Ltd is a unique enterprise based at the Peter MacCallum Cancer Centre that develops and manufactures innovative immune therapies and regenerative medicine products for patients locally as well as for researchers and clinical trial sponsors locally and internationally. It is a growing business with aggressive expansion plans over the next 5 years. You will be responsible for manufacturing complex cell-based therapies for human use in compliance with Good Manufacturing Practice (GMP) and other regulatory requirements such as PIC/S Annexes 1, 2 and 13, and ensuring the facilities remain capable of such manufacture and compliance.

The primary facility is based at the Peter MacCallum Cancer Centre (Peter Mac), Australia’s only public hospital solely dedicated to cancer and one of an elite group of hospitals worldwide to have its own integrated cancer research program and laboratories. You will also provide oversight and operational leadership for affiliated GMP facilities being commissioned in the ASEAN region and Adelaide, Australia.

As a suitably qualified and experienced Facility Manager, you will lead the facility improvement initiatives of our existing and affiliated premises as well as preparing the move to our new 10 cleanroom facility at Peter Mac’s new home at the Victorian Comprehensive Cancer Centre in Parkville in 2016. You will also provide advice and leadership to an experienced technical and scientific team as well as ensure the ongoing GMP compliance of our processes, equipment and facilities. This full time position also requires on-call and recall to duty as well as availability for interstate and international travel.

Duties will include: commissioning and validation of equipment, processes and facilities; ensuring cleanrooms and facilities continually meet operational requirements; managing facility environmental monitoring systems; management and control of equipment and materials; supervision of technical teams; and allocating resources in consultation with internal client service teams and external clients and customers.

Previous experience in GMP compliant facility or quality management is essential. The successful candidate will have well developed communication skills, be able to demonstrate excellent time management and organizational skills, and have strong attention to detail. The successful candidate will also have demonstrated skills and experience in management of manufacturing environments and experience in Blood and Tissues or Manufacture of Sterile Products according to local and international GMP standards. Postgraduate qualifications in regulatory affairs, pharmaceutical or biological sciences and experience with ISO14644 cleanroom requirements as defined in PIC/S annex 1 will be highly regarded. Remuneration will be commensurate with experience. Relocation support may be available in relevant circumstances.

To view the position description please click here Facility Manager Position Description

Applications close Friday 24th October.

Initial enquiries to Dr Dominic Wall – 9656 1069 or Dominic.Wall@Petermac.org

 

Cell Therapy Development Manager

Cell Therapies is seeking a Development Manager to join its leadership team, reporting to the CEO and CSO. Cell Therapies Pty Ltd is a unique enterprise based at the Peter MacCallum Cancer Centre that develops and manufactures innovative immune therapies and regenerative medicine products for patients locally as well as for researchers and clinical trial sponsors locally and internationally. It is a growing business with aggressive expansion plans over the next 5 years. You will be responsible for leading teams of experts developing complex cell-based therapies for human use in compliance with Good Manufacturing Practice (GMP) and other regulatory requirements.

The primary facility is based at the Peter MacCallum Cancer Centre (Peter Mac), Australia’s only public hospital solely dedicated to cancer and one of an elite group of hospitals worldwide to have its own integrated cancer research program and laboratories. You will also provide oversight and project leadership for affiliated cell therapy projects commencing in the ASEAN region and Adelaide, Australia.

As a suitably qualified and experienced Development Manager, you will lead scoping, pricing and resourcing and management of complex cell therapy projects as we rapidly expand our cell therapy product activity in the lead up to our relocation to our new 10 cleanroom facility at Peter Mac’s new home at the Victorian Comprehensive Cancer Centre in Parkville in 2016. You will also provide advice and leadership to an experienced technical and scientific team as well as ensuring successful product development from tech transfer through to contributing to standard of care service delivery. You will also have high-level skills in biological product development with specific advanced expertise in cell-based immunotherapy. This full time position will require availability for interstate and international travel.

Duties will include:  leading and managing project teams and controlling project deliverables according to agreed timelines, consulting and provision of expert advice on cell therapy projects, leading dossier and regulatory submissions for products and trials and allocating project resources in consultation with internal client service teams and external clients and customers.

Previous experience in GMP compliant cell therapy (immunotherapy or regenerative medicine) product development is essential as well as specific expertise with specialized biologicals such as peptides, proteins, viruses, cells or tissues for human therapy . The successful candidate will have well developed communication skills, be able to demonstrate excellent time management and organizational skills, and have strong attention to detail. The successful candidate will also have demonstrated skills and experience in management of biological project teams and experience in local and international GMP standards. Advanced Postgraduate qualifications in pharmaceutical or biological sciences and experience with PIC/S annexes will be highly regarded. Remuneration will be commensurate with experience. International relocation support may be available in relevant circumstances.

To view the position description please click here Development Manager Position Description

Applications close Friday 31st October.

Initial enquiries to Dr Dominic Wall – 9656 1069 or Dominic.Wall@Petermac.org