Reporting to the Head of Bioscience, you will be responsible for overseeing the development and transfer of biological assays and other biological processes into a microfluidic, IVD environment. You will play an integral role in product development projects and be required to manage internal and external stakeholders, mentor and coach staff, and contribute to continuous improvement activities in the Biotranslation team.
- Provide guidance and expertise to assay development and translation activities
- Design, execute, and oversee experiments, including analysis and interpretation of results
- Write test plans, test reports, and other necessary documents to support assay development activities
- Interact with clients to support project and Business Development activities
- Ensure all data is managed effectively and records are maintained appropriately in notebooks
- Transfer assays to a microfluidic, IVD environment across a range of product categories
- Mentor team members to achieve excellence and efficiency
- Conduct evaluation of new projects
- Ensure compliance with all quality requirements
- Present experimental data at departmental or project meetings
- Minimum of a Bachelor Degree (Masters/PhD is desirable) in biology, biochemistry, immunology, molecular biology, biotechnology or a life sciences related discipline
- Minimum 5 years' industry experience in Assay Development under a Quality Management System (preferably ISO13485)
- In-depth understanding of Design Control, Validation and Verification processes
- Demonstrated ability in data analysis, scientific report writing and presentation skills
- Excellent attention to detail and problem-solving skills
- A self-starter with the ability to work in cross-functional teams to successfully deliver projects to the highest standards
- Demonstrated experience as a successful team leader, coach and mentor
- Understanding of GMP (Good Manufacturing Practice) regulatory requirements would be advantageous
This is a chance to play a pivotal role in the product development process for a world leader in the global medical diagnostic market.
If your skills and experience match the above criteria, then hit the apply button now.
Applications in Word Format will only be considered (No PDF Documents please)
Questions can be directed to Aya Inazato at Fuse Recruitment on 0423 505 950.