
Development Scientist
- Wexford
- Permanent
- Full-time
- 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 and GLP
- 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.
- Learning and development opportunities to further your career.
- Competitive salary
- Private health insurance
- Life and long term disability insurance
- Company pension contributions
- EAP program
- At least 2 years 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).
- 3rd level Degree in Science or related discipline
- Good verbal and written communication skills
- 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.
- 3rd level Degree in Science or related discipline
- At least 2 years 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
- Good verbal and written communication skills
- Travel to other sites/ countries for the transfer of knowledge etc