PURPOSE OF THE JOBThis qualified and motivated Senior Scientist will join a dynamic R&D team developing novel assays. The individual will conceive, plan, design, and conduct advanced studies, anticipate, recognize, and resolve technical problems, act as an independent contributor or lead scientist, and coordinate with other groups on project development and improvement. The candidate will analyze data from multiple experiments, formulate conclusions, determine future experiments, and will have expertise in molecular biology and protein chemistry techniques for protein expression and assay development. The successful candidate must possess strong analytical and quantitative skills, excellent oral and written communication skills, and a track record of successful independent and collaborative research.MAJOR RESPONSIBILITIESApply advanced scientific knowledge to projects; conceive, design, plan, and coordinate advanced independent and collaborative studies required for product development.Implement and maintain the effectiveness of the quality system, understanding and following documented procedures, and participate in routine maintenance and lab safety.Prioritize studies and activities to align with project goals and ensure timely project completion, understanding both theoretical and practical aspects of assay design and product development.Maintain a high level of professional expertise by staying current with scientific literature, technologies, and products; develop and maintain internal and external customer contacts.Make difficult technical decisions regarding project priorities while ensuring the buy‑in of teams and leaders.Provide technical leadership and clear direction to the R&D organization across multiple sites in lateral flow and in vitro diagnostic devices.Provide technical and scientific leadership to other team members, including assistance in study design and training/coaching 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 consulting providers.Collaborate closely with Quality, Manufacturing, and Regulatory to support external audits and certification activities, including preparation and response to audit findings.EDUCATION & COMPETENCIES10+ years of in vitro diagnostics / assay development and biologics experience with a strong molecular and biochemical background.Skill in optimizing assay design and conditions, including DOE optimization where appropriate.Advanced skills in statistical analysis.Expertise in design and optimization of serological diagnostic tests.Willingness 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, ensuring timely completion of assigned tasks.Strong analytical and quantitative skills.
#J-18808-Ljbffr