23 Sep
|
Arovella Therapeutics ASX: ALA
|
Melbourne
23 Sep
Arovella Therapeutics ASX: ALA
Melbourne
Arovella Therapeutics (ASX: ALA) is a clinical-stage biotechnology company developing next-generation invariant natural killer T (iNKT) cell therapies for cancer and autoimmune diseases. Our lead product, ALA-101, is an allogeneic CD19-targeting CAR-iNKT cell therapy currently in Phase I clinical evaluation for B-cell lymphomas and leukaemias. Leveraging the unique biology of iNKT cells, Arovella is building a pipeline of off-the-shelf therapies incorporating creative targeting, armouring and alloprotection technologies designed to enhance efficacy, improve scalability and broaden patient access. Beyond haematological malignancies, our pipeline is expanding into solid tumours and autoimmune diseases, creating opportunities to address significant unmet medical needs. Based in Melbourne, Arovella offers the opportunity to contribute to the development of transformative cell therapies from discovery through clinical translation and process scale-up, helping advance robust, commercial-scale GMP manufacturing platforms capable of delivering allogeneic therapies to patients worldwide.
The Role
We are seeking a motivated Process Development Scientist / Senior Scientist to join our growing team at the Jumar Bioincubator in Melbourne. The successful candidate will contribute to the development, optimisation, scale-up and characterisation of manufacturing processes for Arovella's CAR-iNKT cell therapy products. This role is ideal for an individual with experience in cell therapy, bioprocess development or advanced therapy medicinal products (ATMPs), and a strong interest in translating laboratory processes into robust, GMP-compatible manufacturing platforms.
Key Responsibilities
- Design,
execute and analyse process development studies to optimise CAR-iNKT cell manufacturing processes.
- Lead optimisation of critical unit operations including cell activation, transduction, expansion, harvest, formulation and cryopreservation.
- Apply Design of Experiments (DoE) and statistical methodologies identify critical process parameters, understand process/product relationships, and improve process robustness and consistency.
- Develop and utilise scaled-down manufacturing models to support process understanding, robustness studies and technology transfer activities.
- Characterise process intermediates and final cell products using phenotypic, functional and molecular assays.
- Support process scale-up, GMP readiness and transfer of manufacturing processes to CDMO partners.
- Provide technical support for process development, technology transfer and GMP manufacturing activities, including review and interpretation of manufacturing data.
- Analyse and interpret experimental data, prepare technical reports and present findings to internal and external stakeholders.
- Contribute to manufacturing investigations, batch record reviews, SOP development and process documentation.
- Maintain accurate records using electronic laboratory notebook and data management systems.
- Support a safe and compliant laboratory environment, including work with primary human cells, viral vectors and tumour cell lines.
Qualifications and Experience
- PhD or MSc/BSc in Biotechnology, Bioprocess Engineering, Immunology, Cell Biology, or a related discipline.
- Hands-on process development experience in cell therapy, cellular immunotherapy, viral vector, biologics or bioprocess development; experience with CAR-T, T cell or other engineered immune-cell products is strongly preferred.
- Demonstrated experience in process optimisation and experimental design, including Design of Experiments (DoE).
- Strong data analysis, statistical interpretation and scientific communication skills.
- Experience with primary human cell culture and flow cytometry.
- Experience developing or optimizing one or more cell therapy unit operations such as activation, gene transfer/transduction, expansion, harvest, formulation or cryopreservation.
- Understanding of GMP principles, technology transfer and CMC development is highly desirable.
- Experience supporting manufacturing scale-up of advanced therapies will be viewed favourably.
What We Offer
- Opportunity to contribute to the development of first-in-class allogeneic CAR-iNKT therapies.
- Exposure to clinical-stage cell therapy development and CMC strategy.
- A collaborative, agile and scientifically driven environment.
- Flexibility for appointment at Scientist or Senior Scientist level based on experience and expertise.
Type: Full-time
Candidates with solid expertise in process development, bioprocess engineering, statistical process optimisation and technology transfer are particularly encouraged to apply, even if their prior experience is not exclusively in cell therapy.
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📌 Process Development Scientist / Senior Scientist - Cell Therapy (Melbourne)
🏢 Arovella Therapeutics ASX: ALA
📍 Melbourne