Metabolomic Diagnostics Ltd is an early stage biotechnology company located in Cork, Ireland. The company is developing novel and innovative tests to predict pregnancy related complications prior to their clinical manifestation by the detection and quantification of metabolites present in the blood during pregnancy. We are currently seeking an experienced and enthusiastic individual to work as a Development Analyst to join our R&D team. The successful applicant should have experience working in a regulated laboratory environment.
- Work as part of the Product Development team on the day-to-day lab activities
- Collaborate with QA and R&D scientists in the development and validation of robust analytical test methods, including transfer to and training of QC operations
- Perform first-time right analysis using LC-MS with minimal personal OOS results
- Ensure the proper and timely preparation of protocols, reports, technical reviews, risk analysis and other documents
- Review analytical results and provide analytical support in troubleshooting
- Support New Product Introductions
- Carry out stability testing and troubleshoot OOS.
- BSc or MSc in Analytical Sciences or related field
- Relevant experience in Pharma, Biotech and/or in IVD industry (minimum 2 years)
- Good understanding of basic chromatographic techniques
- Ability to work without direct supervision within a team environment
- Effective problem-solving and decision-making skills
- Able to maintain complete and accurate records and work in accordance with established procedures
- Good time management skills and ability to meet and accommodate multiple deadlines simultaneously
- Willing to operate in a flexible manner and be able to switch priorities at short notice.
- Proactive and self-motivated
- Experience in in vitro diagnostics would be a distinctive advantage
- Experience in new product development in a HPRA/FDA site would be highly desirable
- Strong awareness of medical device regulations (ISO 13485, 21CFR 820) and international guidelines for bioanalytical method validation (EMA, FDA, CLSI) would be a strong asset
- Experience in biological sample handling and sample preparation would be beneficial
- Previous experience of supporting laboratory investigation, deviations, change controls, change notices.
- Good knowledge of statistical techniques is desirable.
Working with Metabolomic Diagnostics:
The position presents a unique opportunity to be part of a dynamic, international team focussed on delivering novel diagnostic solutions to the market. As a member of the R&D team, you will be contributing to the product development process. Metabolomic Diagnostics offer a competitive salary package and opportunities for career development.
Contact: Interested applicants should contact: email@example.com