- Apply advanced scientific knowledge to lateral flow assays and devices. Conceive / design / plan / coordinate advanced independent and collaborative studies required for product development. Optimize assay conditions, improve product design and related processes and procedures, and troubleshoot technical issues.
- Apply the appropriate design control measures required at each critical phase of product lifecycle
- Be responsible for implementing and maintaining the effectiveness of the quality system. Understand and consistently follow documented procedures..
- Prioritize studies and activities to align with project goals and be responsible for timely project completion. Understand both theoretical and practical aspects of assay design and product development.
- Maintain a high level of professional expertise by staying current with scientific and industry literature, technologies and products. Develop and maintain internal and external customer contacts to maintain technical knowledge as required to accomplish objectives.
- Competent in making difficult technical decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders.
- Provide technical leadership and clear direction to the Scientific & Technical organization across multiple sites in the area of lateral flow and invitro diagnostic devices.
- Provide technical and scientific leadership to other team members including providing assistance in study design. Provide training/coaching to lower level scientists.
- Create and maintain development standards, training programs and operating procedures that ensure all development activities meet regulatory guidelines and comply with the Quality System.
- Develop and maintain relationships with third level institutions, engineering test labs, key suppliers and appropriate consulting work providers.
- Collaborate closely with functional areas such as Quality, R&D, Manufacturing and Regulatory to support external audits and certification activities. This includes preparation as well as response to the audit findings.
- 10+ years of invitro diagnostics / assay development and biologics essential with a strong Molecular and Biochemical background.
- Skill in optimizing assay design and conditions, including DOE optimization where appropriate.
- Skills in conducting root cause analysis and deep dives in technical troubleshooting
- Advanced skills in statistical analysis.
- Expertise in design and optimization of in vitro diagnostic tests.
- Willing to take on new and challenging assignments and to implement new ideas or alternative solutions.
- Capable of adjusting to dynamic working environment and changing priorities, and of ensuring timely completion of assigned tasks.
- Strong analytical and quantitative skills.
Senior Scientist/Principal Scientist - Galway, Ireland - Abbott Laboratories
Description
About Abbott
Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life.
Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.
Description:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. For more than 125 years, we've brought new products and technologies to the world and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Today our 107,000 colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.
Responsibilities and Duties:
This qualified and motivated Senior / Principal scientist will join a dynamic scientific and technical team providing solutions to a wide range of lateral flow medical devices. This individual will conceive, plan, design, and conduct advanced scientific studies. He or she will anticipate, recognize, and resolve technical problems. He or she will act as independent contributor or lead scientist and will interact/coordinate with other groups and functions on project development and improvement. The candidate will analyze data from multiple experiments, formulates conclusions, and determines future experiments. The candidate should have expertise in molecular biology and protein chemistry techniques for protein expression and assay development. 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.
Requirements:
Education & Experience: