Development Scientist

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.

The successful candidate will:

• Perform and plan design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products.
• 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.
• Create and revise laboratory SOPs as required
• Travel to other sites/ countries for the transfer of knowledge etc.

In return you will receive:

• Learning and development opportunities to further your career.
• Competitive salary
• Private health insurance
• Life and long term disability insurance
• Company pension contributions
• EAP program

• 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.
• Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
• Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
• Familiarity with basic laboratory procedures including gravimetric and volumetric preparations.
• Microsoft excel training or substantial experience utilizing excel is required. Ability to use Macros is desirable.

Experience Desired:

• Product development and design experience- Experience working in an R&D environment (pharmaceutical or medical device) or a Clinical laboratory would be advantageous.
• Understanding of the requirements of quality management systems- ISO13485 & 21CFR820
• Knowledge of Non Conformance, Change Control and CAPA systems                                  #LI-CB1