OverviewSenior scientist will join a dynamic R&D team developing novel assays. The role involves independently managing complex, long-duration projects, product improvements and investigations; anticipating, recognizing, and resolving technical problems; coordinating with other groups on project development and innovation; analyzing data from multiple experiments; and developing expertise in molecular biology and protein chemistry techniques for protein expression and assay development. The candidate should have strong analytical and quantitative skills, excellent oral and written communication, and a track record of independent and collaborative research.Job ResponsibilitiesProject Management: independently manage cross-functional stakeholders to ensure R&D project alignment and compliance with predefined target product profiles.Apply advanced scientific knowledge to conceive, design, plan, coordinate and execute independent and collaborative studies required for product development; optimize assay conditions, improve product design, troubleshoot technical issues.Implement and maintain the effectiveness of the quality system and adhere to strict design control procedures.Participate in routine maintenance and lab safety.Prioritize studies and activities to align with project goals and ensure timely project completion; understand theoretical and practical aspects of assay design and product development.Stay current with scientific and industry literature; develop and maintain internal and external customer contacts to maintain technical knowledge as required.Make difficult technical decisions regarding priorities among projects while ensuring buy-in from teams and leaders.Provide technical leadership and clear direction to the R&D 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 assistance in study design; provide training and coaching to lower-level scientists.Create and maintain development standards, training programs and operating procedures to ensure 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 providers.Collaborate with Quality, Manufacturing and Regulatory to support external audits and certification activities, including preparation and response to audit findings.Job Requirements10+ 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.Expertise in design and optimization of serological 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, ensuring timely completion of tasks.Knowledge of regulatory standards and guidelines in the diagnostics industry is desirable.Advanced skills in statistical analysis.Strong analytical and quantitative skills.Leadership CharacteristicsMaking Complex Decisions: excellent problem-solving methodology using industry-accepted concepts and tools to solve complex technical problems creatively and effectively; complex problem solving and decision-making based on available data; leverage experience with an open and collaborative style.Communicating EffectivelyWrites and presents effectively; adjusts to fit the audience and message; clearly conveys the intended message; proficiency in technical writing for data summaries and technical reports.Managing Diverse RelationshipsEffective at building strong cross-functional relationships with key stakeholders; ability to develop relationships and collaborate with external suppliers and key opinion leaders within related industries.Acting with IntegrityPerson of high character; acts in line with values and beliefs; is direct and transparent while maintaining confidences.EducationMinimum Education: Ph.D. with 5 years of research experience, or B.S./M.S. with 10 years of industrial experience.
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