**About us**:
The Bionics Institute is an internationally recognised, independent medical research institute that solves medical challenges with technology.
We lead the world in the research and development of innovative medical devices and therapies to improve human health. Our multidisciplinary team comprises world-class scientists, engineers and researchers, and our laboratories are located in St Vincent's Hospital Melbourne, close to our clinical collaborators.
Together we transform the lives of people with a range of conditions, including hearing impairment, Crohn's disease, Parkinson's disease, epilepsy, stroke and arthritis
**About you**:
The incumbent will have experience in quality-controlled manufacturing processes in a research and development and/or industrial environment.
The incumbent will have experience in chemical synthesis and/or nanoparticle synthesis in a laboratory.
The incumbent, working under supervision of the Technology Development Officer Yingjie Hu and Associate Professor Andrew Wise, will be required to work independently and to a high quality.
The incumbent will exhibit a high level of attention to detail and be able to work within a regulatory framework required for clinical translation of medical technology.
**About the role**:
The Bionics Institute has developed a particle-based drug delivery platform to deliver therapeutic drugs to the inner ear for the treatment of hearing loss.
The project is entering an exciting phase in preparation for clinical translation.
A key objective of the role is to support the transfer of a pre-production stage manufacturing process through to clinical grade manufacturing.
Working in the Bionics Institute's ISO9001 Quality Framework Facility, the Manufacturing & Research Technician will implement a developed manufacturing process for the drug delivery platform to manufacture and test nano and microparticles on a daily basis according to specifications.
The role will also contribute to innovative pre-clinical research studies to evaluate, optimise, and further develop the therapeutic platform.
The incumbent will contribute to the review and continuous improvement of Standard Operating Procedures and quality control measures, including process redesign and equipment upgrade.
**Key responsibilities**:
- Manufacture drug delivery particle systems under quality-controlled processes enabling clinical-grade production.
- Quality control testing of drug delivery systems using drug assays and in vitro culturing techniques.
- Contribute to ongoing research projects utilising drug delivery systems.
- Contribute to the development of new quality control processes and techniques to test and maintain high-quality manufacturing processes.
- Generate, maintain, and update documents including Standard Operating Procedures/Risk Assessments/Lab Notebooks.
- Responsible for data management for all manufacturing processes, including:
- Ensuring that accurate and timely records of all manufacturing and experiment-related data are kept and made accessible in appropriate formats for further use.
- Managing backups of digital data from manufacturing.
- Compiling accurate and timely records.
- Coordinate the pre-production line equipment maintenance and updates
**Core competencies for the role**:
**Task complexity - Routine**
The incumbent will conduct routine manufacturing of drug delivery particle systems under quality-controlled processes following a standard procedure and contribute to the ongoing preclinical research under the supervision of the Supervisor.
**Knowledge required - General**
Theoretical knowledge and practical experience of manufacturing processes and research equipment.
Knowledge of up-to-date professional standards and assays used for quality control testing.
Sound knowledge and experience in chemical (nano)particle fabrication is highly desired.
**Level of supervision and independence - Routine**
Whilst some direction is provided by the Supervisor, the incumbent is expected to work autonomously and exhibit initiative and flexibility.
**Judgement and problem solving - Derivative**
The incumbent is responsible for reviewing and developing their role and is expected to have the ability to research and recommend effective solutions to problems, as and when required.
**Organisational relationships and impact - Established**
The incumbent is expected to be able to communicate effectively to others regarding procedures, requirements and tasks within their core responsibilities.
The incumbent is required to work within a multi-disciplinary team structure and exhibit a high level of organisation in order to achieve required tasks.
**Essential Selection Criteria**:
- Experience in clinical grade manufacturing systems and processes including quality control and root cause failure analysis for medical research.
- Sound knowledge and experience in chemical engineering and nanoparticle fabrication. Knowledge in silica particl