Position: Associate Staff Scientist - Product Lifecycle Specialist Location: Salt Lake City, UT At bioMérieux, we are dedicated to advancing healthcare through innovative diagnostic solutions. Join our team of scientific leaders and be part of a dynamic group that is shaping the future of in vitro diagnostic (IVD) products. We are seeking a highly motivated Associate Staff Scientist to drive performance studies and documentation in product lifecycle management for the regulatory validation of cutting-edge IVD products. This is an exceptional opportunity for a Master or Bachelor-level scientist to apply their expertise in molecular biology and microbiology while making a tangible impact on global health. As an Associate Staff Scientist at bioMérieux, you will operate proactively and collaboratively in a team in support of pre-market and post-market product performance validation and sustainment activities. You will collaborate with multidisciplinary teams of scientists, engineers, and regulatory experts, ensuring that our products meet the highest standards for safety, performance, and quality. If you're passionate about scientific innovation and want to contribute to meaningful healthcare solutions, this role offers both a challenge and an opportunity to grow within a global leader in diagnostic technology. Why bioMérieux? + Global Impact: Be part of a company that has a lasting impact on global health by developing innovative diagnostic solutions. + Cutting-Edge Research: Engage in groundbreaking work alongside some of the brightest scientific minds in the industry. + Career Growth: We invest in the professional development of our employees, offering a collaborative and supportive environment for personal and career advancement. + Inclusive Culture: Join a team that values diversity, inclusion, and the contributions of each individual. We are committed to fostering a culture of respect, teamwork, and mutual support. Key Responsibilities: + Lead Regulatory Performance Studies: Design and execute performance studies to demonstrate that IVD products function in accordance with regulatory requirements and established performance claims. Lead efforts in data analysis, troubleshooting, and report writing for regulatory submissions related to product lifecycle management. + Respond to Health Authority Questions and Requests: Collect and/or review data and literature to respond to Health Authority questions or requests and to maintain and revise documentation and performance claims through the product lifecycle. + Cross-Functional Collaboration: Collaborate with diverse teams across bioMérieux departments, contributing to strategy development, resource sharing, and innovative problem-solving. Work closely with regulatory, product development, and quality teams to ensure timely and accurate project delivery. + Scientific Guidance and Mentorship: Mentor junior research associates, fostering an environment of continuous learning and professional growth. Provide guidance on experimental design, data analysis, and troubleshooting. + Innovative Solutions: Identify opportunities for process improvements, striving for enhanced accuracy, efficiency, and reliability in laboratory work and documentation. Drive innovation in methodologies and work practices to improve project outcomes. + Regulatory Expertise: Contribute to the writing, technical review, and submission of regulatory documents to the FDA and other regulatory bodies. Stay current with the latest regulatory guidelines and best practices in IVD product development. + Sequence Analysis and Technical Writing: Work as a part of the sequence surveillance team to regularly assess and document product performance claims. Critical thinking and attention to detail are needed in conjunction with a strong foundation in sequence analysis and PCR technology. + Data Analysis and Reporting: Ensure that all study data is evaluated, verified, and accurately reported. Compile study results and present findings through written reports, presentations, and discussions. Contribute to scientific publications, conferences, and patent applications. + Continuous Learning and Development: Stay up-to-date with state-of-the-art developments in molecular biology, microbiology, and diagnostic technology. Maintain a thorough understanding of regulatory requirements and industry trends. Qualifications: + Master’s Degree in a Scientific Discipline (Molecular Biology, Microbiology, or related field) and 6+ years of relevant experience. + OR Exceptional candidates with a Bachelor’s degree and 8+ years of relevant experience, preferably in a clinical or industrial setting, may also be considered. + Hands-On Experience: Expertise in molecular biology and microbiology laboratory techniques, with competency in PCR technology and sequence analysis. + Leadership and Mentorship: Demonstrated mentorship experience preferred. + Technical Writing: Technical writing experience in a professional setting preferred. + Regulatory Knowledge: Familiarity with regulatory requirements for IVD products, including FDA submissions and international guidelines, is a plus. Skills and Attributes: + Collaboration and Teamwork: Excellent interpersonal skills and the ability to engage effectively with cross-functional teams. Comfort working with scientists, engineers, regulatory professionals, and project managers from diverse backgrounds. + Communication Excellence: Strong written and oral communication skills, with the ability to write clear, concise study reports, research findings, and regulatory submissions. + Analytical Thinking: Exceptional problem-solving skills, with the ability to independently design experiments, analyze complex data, and troubleshoot challenges in real-time. + Project Management: Highly organized, with the ability to manage multiple projects simultaneously while ensuring timelines and milestones are met. + Biosafety Laboratory Work: Ability to work in a biosafety laboratory environment and comply with safety and equipment use requirements. If you're ready to take on a challenging and rewarding role in the field of IVD product validation and contribute to cutting-edge healthcare innovations, we encourage you to apply!