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Senior Scientist I, Product Development

alamarbiosciences · Fremont, California · Fremont, California, United States
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<div class="content-intro"><p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.</span></p></div><p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">We are seeking a highly motivated Senior Scientist I to join the Product Development team and support New Product Introduction (NPI). This role focuses on downstream product development, including QC method development, analytical strategy, verification and validation (V&V), and technology transfer of assays and reagents from R&D to Manufacturing. Working at the interface of R&D and Operations, the Product Development team ensures that products are robust, scalable, and suitable for reliable manufacturing and commercialization.</span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Duties and Responsibilities</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Design and execute verification and validation (V&V) studies to assess precision, sensitivity, linearity, robustness, and other key performance characteristics.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Lead end-to-end product development with ownership across the full product lifecycle.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Design, develop, and optimize QC methods to characterize assay performance, reagent quality, and product consistency.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Lead or support product and process transfers to Manufacturing and QC team, including technical documentation, process implementation, and training.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Collaborate cross-functionally with R&D, Manufacturing, QC, Quality, and Engineering teams to ensure successful product development and transfer.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Lead or support root cause investigations and continuous improvement initiatives to improve product quality, process robustness, and manufacturing efficiency.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Qualifications</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">D. in Biochemistry, Molecular Biology, Immunology, or a related discipline with 5+ years of relevant industry experience, or an M.S. with 8+ years of relevant industry experience.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Demonstrated experience leading or supporting NPI and product transfer initiatives for commercial biotech tools or diagnostic products.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong expertise in QC method development, analytical validation, and technology transfer to Manufacturing.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience authoring technical documentation, including SOPs, validation reports, and technology transfer documents.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong problem-solving, troubleshooting, and analytical skills.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience with immunoassays (e.g., ELISA, MSD, Simoa) and molecular assays (e.g., qPCR, ddPCR, NGS).</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience working in IVD or other regulated environments, with familiarity with quality systems such as ISO 13485.</span></li> &l

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