Senior Scientist I, IVD Assay Development

Senior Scientist I, IVD Assay DevelopmentFremont, CaliforniaAt 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.The IVD Assay Development Senior Scientist I will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications. This role requires hands-on laboratory work, regulatory compliance, and cross-functional collaboration to ensure successful product development and commercialization.Key ResponsibilitiesDevelop IVD assays for FDA and other global regulatory approval/clearanceDesign and execute experiments to develop IVD assays and establish assay performance specifications (sensitivity, specificity, reproducibility)Optimize and troubleshoot assays to meet performance expectationsTransfer assay designs to tech transfer and manufacturing; define QC measures and support scale-up activitiesWork closely with R&D, Quality, Regulatory Affairs, and Engineering teams.Participate in technical discussions and project meetings.Design and execution of verification and validation (V&V) studies, including all testing and documentationPerform data analysis and generate study reports suitable for regulatory reviewIdentify and troubleshoot assay or process issues, recommend solutions, and contribute ideas for assay and process improvementsStay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologiesPerform other duties as requiredRequirementsPh.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields.5+ years in IVD assay development and validation.Hands-on experience with immunoassay formats (ELISA, chemiluminescent), enzymatic assays, and molecular techniques (qPCR, sequencing).Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485).Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software).Excellent documentation and communication skills.The base salary range for this full-time position is $140,000 - $165,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.Voluntary Self-IdentificationFor government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary and will not be considered in the hiring process. Any information you provide will be confidential.As a federal contractor subject to VEVRAA, we request this information to measure outreach and recruitment efforts. Classification of protected categories is as follows:A "disabled veteran" means a veteran with a service-connected disability or eligible for compensation.A "recently separated veteran" means a veteran within three years of discharge.An "active duty wartime or campaign badge veteran" means a veteran who served during a war or campaign with a campaign badge.An "Armed forces service medal veteran" means a veteran who participated in a U.S. military operation with an Armed Forces service medal.Select...Voluntary Self-Identification of DisabilityForm CC-305OMB Control Number 1250-0005Expires 04/30/2026 #J-18808-Ljbffr