Senior Scientist / Principal Scientist Our Client, a global healthcare leader, is currently searching for a motivated Senior Scientist / Principal Scientist to join a dynamic scientific and technical team providing solutions to a wide range of lateral flow medical devices. You will conceive, plan, design, and conduct advanced scientific studies. You will anticipate, recognize, and resolve technical problems. They will act as an independent contributor or lead scientist and will interact/coordinate with other groups and functions on project development and improvement.
RESPONSIBILITIES: Apply advanced scientific knowledge to lateral flow assays and devices. Conceive, design, plan, and 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 the 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 in vitro 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.REQUIREMENTS: 10+ years of in vitro 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 a dynamic working environment and changing priorities.Strong analytical and quantitative skills.If interested, please forward your most updated CV to ******
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