Reporting to the Head of Bioscience, and working with a team of scientists, you will develop, test, and transfer biological assays into medical device/IVD products.
The successful candidate will design and execute experiments to develop and verify biological assays across all phases of the product development process. Serving as a subject matter expert in biological assays, you will be able to analyse scientific methods and results, propose novel strategies and independently apply basic scientific principles to solve analytical problems and troubleshoot assays. You will have a demonstrated ability to work on multiple projects in parallel and meet strict timelines.
You will be able to effectively communicate with cross-functional project teams providing regular updates on progress to internal and external stakeholders through both written reports and verbal presentation of scientific data.
This multi-faceted, hands on role, will require the applicant to possess skills and experience in biochemistry, immunology and molecular biology.
Essential Skills and Requirements:
- Minimum of a Bachelor degree (honours or masters/PhD would be desirable) in biology, biochemistry, immunology, molecular biology, biotechnology or life sciences related.
- Experience working in a biotechnology company and a sound understanding of Good Laboratory Practices (GLP).
- Experience developing and testing immunological and molecular diagnostic assays
- Excellent problem-solving skills
- A self-starter with a strong ability to work independently
- Outstanding communication skills
- Well organised; able to plan and work appropriately
- Ability to work effectively in a team
- Competence in data analysis and reporting
- Attention to detail
- Understanding of GSP (Good Scientific Practice) and GMP (Good Manufacturing Practice) regulatory requirements in pharmaceutical drug development
- Understanding in assay validation
- Scientific report writing and presentation skills
- Mechanical aptitude and problem-solving skills
The responsibilities of this role are (but not limited to):
- Design and execute experiments coupled with the analysis of the results
- Respond to customer requirements and liaising with suppliers
- Conduct test protocols and procedures and product evaluation
- Transfer new technologies across a range of product categories
- Write technical reports and document development work
- Develop new assays in line with project and customer requirements
- Perform independent experimental work and record of data into workbooks
- Prepare draft assay qualification/validation protocols for new test methods
- Collate, present and analyse experimental data in consultation with the Manager and Project Manager
- Support quality systems and ensure department compliance with all GSP and GMP requirements, as appropriate
- Write reports for assay validation
- Draft of Test Procedures for assays, or SOP (Standard Operating Procedures) for equipment used within the department, for approval by Senior Scientist and QA (Quality Assurance)
- Document assay results, and report into Sample Manager, or to other Product Development
- departments, as required
- Present experimental data at departmental or project meetings
- Ensure critical instruments are calibrated and calibration records are maintained
If your skills and experience match the above criteria, then please apply with your CV and covering letter in Word format.
Questions can be directed to Aya Inazato at Fuse Recruitment on 0423 505 950.