The officer will be required to but not exclusive to:
· Work in an innovative, high-spirited, and fun environment to test, develop and optimize molecular, immuno-diagnostics assays and novel analytical platform.
· Drive technical aspects of assigned project.
· Work independently to plan, execute, assess, and evaluate efficiency and efficacy of experiments for the development and optimization of molecular and immuno diagnostics assay and novel analytical platforms.
· Apply design control and phase gate driven product development processes for the development of medical device systems and hardware platform products in accordance with ISO 13485.
· Communicate with internal and external stakeholders on progress of experiments, present and interpret experimental results and make recommendations on ways to optimize product development in accordance with ISO13485.
· Write design optimization and verification plans and reports in accordance with ISO 13485.
· Write/contribute to project scoping/planning and proposals.
· Handle and perform routine sample preparation of biological and clinical samples (eg. serum, plasma, cells, and tissue).
· Execute product development experiments and data analysis.
· Conduct validation and verification test based on ISO 13485 processes.
The ideal candidate should possess the following qualities:
· A PhD or Master’s Degree in Life Sciences / Molecular Biotechnology / Biotechnology / BioEngineering or a related discipline.
· Work Experience
- 1+ years of diagnostics industry experience inclusive of diagnostics assay product development, reagent optimization, analytical and clinical validation, and quality control in the fields of oncology and infectious diseases.
- Prior in-depth experience in the following is highly desired: molecular and immune diagnostic assay product development and optimization; cartridge-based assay development; clinical mass spectrometry; DNA sequencing.
- Good track record of diagnostic development and/or product delivery is highly desired.
· Technical Skills
- Ability to work independently to plan and execute, assess, and evaluate efficiency and efficacy of experiments in the development and optimization of molecular and immuno diagnostic assays and novel analytical platforms.
- In-depth working knowledge of molecular and immuno diagnostic assays fundamental.
- Presentation and interpretation of results to internal and external stake holders.
- Mentoring of junior scientists in skills development.
· Soft Skills:
- Creative problem solving.
- Well organised and ability to multitask.
- Effective communicator and good people management skills.
- Report writing and presentation skills, including numeracy skills, information literacy and writing skills.
- Enjoys working in a dynamic environment to progress project.
- Ability to work independent and as a team.
· Abilities / Aptitudes
- Individual who is highly motivated, proactive, and adaptable to work exigencies.
- Experience in applying design control and phase gate driven product development processes for the development of medical device systems and hardware platform products in accordance with ISO 13485.
- Good understanding of applicable medical device regulations and design control processes that comply with the ISO 13485, FDA 21 CFA Part 820 and the 98/79/EC IVD and MDD Directives.