Reagent Manufacturing Associate I

About the role

About Karius Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions. Position Summary As a Reagent Manufacturing Associate I, you will support the production of critical reagents used in Karius' NGS-based infectious disease diagnostic assays. This role is hands-on and process-focused, with responsibility for manufacturing and qualifying reagents, supporting RUO and IVD product workflows, performing quality testing, and maintaining accurate documentation in an ISO 13485-compliant environment. You will work closely with scientific and operational teams to support equipment readiness, material management, troubleshooting, validation activities, and continuous process improvement. The ideal candidate is detail-oriented, reliable, and comfortable working with chemical and biological materials in a fast-paced manufacturing setting where quality, consistency, and patient impact are central to the work. Why Should You Join Us? Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company's platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale. Reports to: Sr. Manager, Manufacturing and Technical Operations Location: Redwood City, CA Primary Responsibilities Support equipment qualification activities, including IQ/OQ/PQ, preventive maintenance, routine maintenance, basic troubleshooting, and required documentation in accordance with ISO 13485 requirements. Assist with planning and execution of validation activities, including reagent stability studies, shelf-life extension testing, documentation, and data review. Perform reagent manufacturing activities, including formulation, filling, labeling, assembly, packaging, material handling, in-process quality checks, and accurate batch documentation for RUO and IVD products. Receive, inspect, label, store, stage, and reconcile raw materials, components, and finished goods while maintaining accurate lot control, FIFO usage, traceability, and inventory records. Prepare work orders, stage materials, support line setup, verify material identity and quality, print labels using controlled templates, and perform manual or semi-automated operations such as pipetting, capping, and sealing tubes and 96-well plates. Perform in-process and lot-release QC testing for clinical diagnostic reagent manufacturing, support data analysis, review results for accuracy and completeness, and escalate issues as appropriate. Follow SOPs and work instructions, maintain organized manufacturing records, and assist with drafting or revising SOPs, batch records, work instructions, and material specifications. Assist in identifying, documenting, escalating, and supporting resolution of nonconformance events, deviations, CAPAs, and related root cause investigations. What's Fun About the Job? Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters. Travel: No travel required. Physical Requirements Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment. Position Requirements Bachelor's degree in Biology, Molecular Biology, Genetics, Chemistry, Biochemistry, or a related field preferred. An Associate's degree in a life sciences field, or High School Diploma/GED with relevant experience, may be considered. 0-2 years of relevant laboratory, reagent manufacturing, life sciences production, or regulated manufacturing experience. Basic hands-on molecular biology experience

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