Overview:
An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The team is responsible for a diverse range of activities including analytical development, product development, verification and validation and on-market support.

Responsibilities:

• Lead product development team, supervise laboratory work for product development staff. Train and mentor new technical staff.
• Plan and perform design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products meeting the guidance documentation e.g CLSI.
• Troubleshoot atypical results and lead investigations to identify root cause.
• Develop, test and refine prototype products.
• Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
• Plan day to day activities, ensure sufficient supplies of materials to carry out tasks etc and organise all proficiency testing within the laboratory.
• Carry out work in accordance with defined processes and laboratory procedures.
• Ensure that all work is compliant within the existing quality processes.
• Perform investigative work as required by the organization to support reagent kits
• Maintain detailed experimental records.

Qualifications:

EDUCATION:

A degree in a scientific subject with a strong chemistry component and / or equivalent years’ experience in industry.

EXPERIENCE:

• Proven experience of working in a laboratory with analytical equipment such as HPLC or UPLC. Practical experience of LC/MS/MS would be an advantage.
• Knowledge of the design control process and/or with demonstrable effective experience in a development role (5 years+ ideally)

• Lead product development team, supervise laboratory work for product development staff. Train and mentor new technical staff.
• Plan and perform design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products meeting the guidance documentation e.g CLSI.
• Troubleshoot atypical results and lead investigations to identify root cause.
• Develop, test and refine prototype products.
• Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
• Plan day to day activities, ensure sufficient supplies of materials to carry out tasks etc and organise all proficiency testing within the laboratory.
• Carry out work in accordance with defined processes and laboratory procedures.
• Ensure that all work is compliant within the existing quality processes.
• Perform investigative work as required by the organization to support reagent kits
• Maintain detailed experimental records