Job Description
Our client based in Galway is seeking an experienced R&D Scientist to join their team. This qualified and motivated person will join a dynamic R&D team and will support studies to design and screen novel biologics for immunoassay development. The successful candidate will analyse data from multiple experiments, formulate conclusions, and determine future experiments. The successful candidate must have strong analytical and quantitative skills, excellent oral and written communication skills, and a track record of successful independent and collaborative research.
Key Responsibilities:
1. Project Management: Manage product and process improvements independently using established principles and procedures
2. Product Development lifecycle: Apply advanced scientific knowledge to projects. Conceive / design / plan / coordinate advanced independent and collaborative studies required for immunoassay development. Complete internal projects, investigations, and literature reviews independently across R&D projects. Optimize assay conditions, improve product design and related processes and procedures, and troubleshoot technical issues
3. Product and Process Improvements: Proactively investigates and supports in addressing technical investigations and process improvements in NPI lifecycle. May perform or support test and process method modifications. Recognize adverse trends and emerging issues. Propose and implement solutions to issues
4. Design control and risk management: By standard practice independently develops, and maintains risk management files and organizes data for risk management evaluation and decisions
5. Problem solving and investigations: Manage investigations, identify root cause and drive to resolution with minimal supervision. Applies information and methods for problem solving. Arrives at timely conclusions and proposes next steps. Capable of resolving recurrent problems. Thinking is guided by standard practice/precedent. Provides audit inputs and support as required
6. Technical Documentation: Draft and submit defined procedures, to perform testing and data analysis in support of product development lifecycle and root cause investigations
7. Sharing Knowledge: Presents technical information to management and may present externally to customers. Shares knowledge and expertise with others in work group. Mentors or teaches others to facilitate timely resolution of product and process technical issues. Develops and maintains internal and external customer contacts to maintain technical knowledge as required to accomplish objectives. Collaborate closely with functional areas such as Quality, Design Assurance, Manufacturing and Regulatory to support product design. Develop and maintain relationships with third level institutions, engineering test labs, key suppliers and appropriate consulting work providers
8. Safety & Quality Compliance: Understand and consistently follow documented procedures. Actively participate in routine maintenance, lab safety and audits
9. Results Orientated: Maintains a high level of professional expertise by staying current with scientific and industry literature, technologies and products.
Requirements:
10. Assay development and biologics experience with a strong Molecular and Biochemical background
11. Skill in optimizing assay design and conditions, including DOE optimization where appropriate
12. Experience working with patient samples and sample management procedures
13. Expertise in design and optimization of serological diagnostic tests is a plus
14. Willing to take on new and challenging assignments and to implement new ideas or alternative solutions
15. Capable of adjusting to dynamic working environment and changing priorities, and of ensuring timely completion of assigned tasks
16. Experience in antibody development and biologics screening assays would be an advantage
17. Knowledge of regulatory standards and guidelines particularly in the diagnostics industry is desirable
18. Advanced skills in statistical analysis
19. Strong analytical and quantitative skills
20. Excellent problem solving methodology
21. Proficiency in technical writing
22. Effective at building strong cross functional relationships with key stakeholders
23. Relevant 3rd level qualification in scientific and/or technical field or relevant combination of education and experience
24. 2 or more years' work experience and advanced degree is desirable.
Benefits
25. Competitive and attractive employee compensation package
26. Pension contributions
27. Health insurance
28. Paid public holidays
Location: Galway, Ireland