Cell Therapy Specialist (Gene Therapy and Cellular Immunotherapies)
Build products and processes in the hottest field of cell based therapies today. Asia Pacific’s leading manufacturer of cell based therapeutics – the essential infrastructure needed to bring transformational therapies to patients. Pipeline of projects in the hottest part of the field – working with leading companies in the field from around the world
Cell Therapies Pty Ltd (CTPL) (www.celltherapies.com.au) is leading the provision of cGMP manufacturing and distribution infrastructure for cell based therapies in the Asia Pacific region. CTPL provides contract translation, process development and clinical trial manufacturing services to product development companies, and then supports commercialisation across the region.
Our expertise, developed since 2001, is “needle-to-needle” ensuring complete product security and control and includes collection management (especially apheresis), cryopreservation, cell processing, distribution and marketing. CTPL operates cell processing facilities at our home base at The Peter MacCallum Cancer Centre (Peter Mac – our parent) in Melbourne and established the first western-Japan cell processing partnership to extend our reach right across Asia.
CTPL has managed numerous cGMP manufacturing licenses with Australia’s Therapeutic Goods Administration and is proud to be working with some of the world’s leading cellular therapy companies. Our product and project pipeline includes immunotherapy (including T-cells and antigen presenting cell therapies for cancer and infectious diseases), gene therapies and regenerative medicine (musculo-skeletal repair).
We have immediate opportunities for enthusiastic and experienced cell therapy development leaders excited by the potential to bring breakthrough therapies to market. Haematology and large (clinical) scale cell culture experience is particularly in demand.
Cell Therapy Specialists report to Project Portfolio Managers and are responsible for the provision of subject matter expertise and project leadership/management during the introduction and optimization of new cellular therapy manufacturing processes. Responsibilities include but not limited to:
- Leading and managing assigned cellular therapy projects
- Providing advanced technical content input for new proposals and contracted projects including
- Process and analytical evaluation
- Technology transfer into (or out of) Cell Therapies facilities from (or to) international manufacturing locations;
- Cell culture and modification process development, optimization or validation
- Clinical trial and commercial production scale manufacturing
Cell Therapy Specialists will participate in diverse project teams and for specific projects will be accountable for leading project delivery. Projects range from process development and technology transfer of novel human cell-based therapies to facility expansions, strategic alliance management and major change programs. Project teams will range from individual technical experts to large cross-functional teams spanning the entire organisation and external providers including clients, clinicians, CRO’s, etc. Clients may require consulting services or contract manufacturing for clinical trials through to commercial manufacturing and distribution under license of cellular and tissue therapy products. All operations are conducted under cGMP conditions.
CTPL is seeking advanced cellular therapy practitioners with deep subject matter expertise in the manufacturing of gene modified cell therapies and cellular immunotherapies to join our growing team in Melbourne. Preferred candidates will be able to demonstrate results and impact through:
- Appropriate qualifications or equivalent in a relevant discipline with specific demonstrable expertise in at least one of: haematology, cellular immunology, gene therapy, transplantation medicine.
- Demonstrated skills and experience in cellular immunotherapy or gene therapy, with specific expertise in human patient cell culture and manipulation in one or more of the following: viral or non-viral gene transfer, stem cell (especially haematopoietic stem cells) expansion and differentiation, blood banking, T-cell or antigen presenting cells preparation for cancer or infectious disease immunotherapy, advanced cell therapy product characterization.
- Skills and experience in working with, developing and managing scientific and technical staff in a matrix environment
- Formal training or experience in regulatory affairs, quality management, clinical trials, statistics/DoE or project management and commercial project and/or alliance management experience will be an advantage
- Experience and prior knowledge of Good Manufacturing Practice (GMP) for Human Blood & Tissues as well as relevant clinical trial frameworks in one or more of ANZ, US or EU will be an advantage
To view the position description click here cell-therapy-specialist-position-description
Salary will be commensurate with experience, track record and fit with selection criteria. International applicants are strongly encouraged and relocation support will be available, subject to meeting the requirements for appropriate residency and work permits for Australia.
Offers of employment will be subject to candidates providing a satisfactory National Police Certificate (police check) or equivalent and satisfactory health and vaccination assessments.
Applications, including a covering letter addressing the selection criteria, key requirements of the role and a current CV should be submitted through Seek https://www.seek.com.au/Job/31850787?_ga=1.240604099.1758055436.1455237552 by Friday 14 October 2016. International applicants are encouraged to apply early as in person interviews may be possible during early October.
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