R&D Scientist - Product Development

Scientist - Product Development At Microbiologics, our impact goes far beyond the lab. As a well-established biotechnology company with a strong reputation for quality, collaboration, and scientific rigor, we develop products that help protect the health and safety of people around the world. We are seeking a Scientist to join our Product Development team, someone who enjoys working at the intersection of scientific innovation, structure, and execution. In this role, you will lead high-complexity new product introductions (NPIs) while also serving as a technical and project leader who brings clarity, consistency, and momentum to development efforts. To Be Considered for This Position, Candidates Must Have the

Following Qualifications:

Ph.D. in Biology, Cell Biology, Molecular Biology, Biochemistry, or a related field5+ years of hands-on industry experience in a laboratory setting (BSL-1 and BSL-2 environments)3+ years of experience in assay design, development, and analytical validation for diagnostic or research applicationsStrong expertise in molecular biology techniques including nucleic acid isolation and quantification (qPCR, RT-PCR, digital droplet PCR)Experience with cloning, multiplex assay design, and primer and probe developmentWorking knowledge of IVD regulatory standards including

FDA 21 CFR

Part 820, ISO 13485:2016, or CLIA Candidates without this combination of industry-based assay development experience and regulatory exposure will not be considered. Only candidates who meet all of the qualifications listed above will be considered. Why This Role Is Different At Microbiologics, Scientists do not work in isolation. In this role, you will: Lead technically complex development initiatives with clear ownership and visibilityInfluence how projects are structured, executed, and documented across Product DevelopmentPartner closely with associates, technicians, and cross-functional teams to drive successWork in an environment that values thoughtful planning, scientific excellence, and collaborationHave opportunities to grow technically and professionally within a supportive, team-oriented culture If you enjoy building strong scientific solutions and strong frameworks that help others succeed, this role offers meaningful impact. What You'll Do Product Development and Scientific Leadership Lead the design, development, and validation of quality control products for molecular diagnostics in compliance with current Good Manufacturing Practices (cGMP)Drive high-complexity New Product Introductions (NPIs) from concept through validation using

FDA 21 CFR 820

Design ControlsServe as a technical and project leader, providing structure and guidance to associates and technicians Molecular Biology and Assay Development Engineer novel control materials using advanced molecular biology techniques including restriction enzyme digestion, ligation, sequencing, RT-PCR, and qPCRApply advanced amplification technologies such as multiplex PCR and related methods to enable sensitive and specific detection or quantification of genetic targetsDesign and optimize assays, including primer and probe development, to meet performance and manufacturability requirements Documentation, Analysis, and Process Improvement Author and contribute to technical documentation including work instructions, validation protocols, technical reports, and presentationsSupport on-market product investigations and continuous improvement activitiesAnalyze and visualize complex datasets using statistical and analytical tools to inform development decisionsIntegrate scientific and engineering principles to optimize workflows and design for manufacturability Who Thrives Here We believe great science is driven by great people. This role is a strong fit for someone who: Brings both technical depth and structured thinking to their workEnjoys leading projects while collaborating closely with othersIs highly goal-oriented and comfortable working against defined timelinesThrives in a fast-paced, collaborative environment where quality and execution matterAligns with our values: We win together. We are driven to achieve. We are brave, bold, and confident. We care. Additional Requirements Ability to pass a background check and drug screening Who We Are Microbiologics is a global biotechnology company and trusted partner to healthcare and life science organizations worldwide. For more than 50 years, we have supported laboratories, manufacturers, and suppliers with high-quality biological control materials, assay services, and consulting across microbiology, molecular diagnostics, and virology. Headquartered in St. Cloud, Minnesota, with additional facilities in California, Kentucky, and Michigan, we are known for our collaborative culture, scientific excellence, and commitment to continuous improvement. What We Offer We offer a comprehensive and competitive benefits package, including: Medical and dental insuranceCompany-funded Health Savings Account (HSA)Life insurance and short- and long-term disability coverage401(k) with generous company matchDaycare assistanceTuition reimbursementBonus potentialOngoing training and professional development opportunitiesA supportive, team-oriented culture focused on growth #LI-CR1