Ref No: AM17289
Co. Dublin, Ireland
Continuous Improvement & R&D Scientist - South Dublin.
This position is being offered initially as an 18 months' fixed-term contract.
In this role you will work within the Continuous Improvement and R&D team to:
- develop new and/or update existing diagnostic reagents,
- develop new and or update existing analyser system test methods.
- integrate new and/or updated products into routine operations including manufacturing, packing and QC test methods.
- be involved in system development and product development projects.
This position will be largely project based and will entail a high degree of autonomy and initiative.
All duties will be performed in an FDA regulated environment where knowledge and adherence to Standard Operating Procedures within the Quality System is required.
• Conduct scientific studies. Analyse data and processes; develop, characterise and make formal recommendations.
• Plan and execute experiments using design of experiment techniques
• Coordinate and assist the formal creation of system test methods in conjunction with the Quality and Regulatory Groups
• Re-engineer existing processes or test methods to adapt to changes in market, business, and/or regulatory requirements.
• Transition products and processes from development phase to routine production
• Work within cross-functional teams to identify key project/process or performance attributes and opportunities for product and process improvements.
• Co-ordinate and lead technical root cause investigations.
• Co-operate with other functional areas and groups within the company to achieve robust product supply
• Participate in product transfer activities
• As required lead complaint investigations within the company and subsequent report handling.
• Completion and review of documentation to cGMP/GDP requirements/standards.
• Work constructively with team members from R&D, Continuous Product Improvement, Marketing, Operations, Quality Assurance, Technical Support, Clinical Affairs, Customer Service, and Finance.
Interested applicants should have:
• A life science degree.
• Laboratory experience in biological sciences required
• Demonstrated competence in biochemical techniques and statistical concepts.
• Experience in the field of Coagulation/ IVD is advantageous.