Reagent Manufacturing Associate I

Karius • Redwood City, CA

6d • Onsite

About The Position

As a Reagent Manufacturing Associate I, you will work alongside scientific leaders in NGS-based infectious disease diagnostics, providing meaningful contributions to making an impact on patients' lives while contributing to the company's growth and development. You will have the opportunity to foster process excellence for a state-of-the-art NGS infectious disease diagnostic assay by manufacturing and qualifying reagents for Karius assays (RUO and IVD). In addition, you will support reagent manufacturing equipment, material management, and ISO 13485-compliant processes, while following procedures in fast-paced environments. The ideal candidate should be a detail-oriented professional with hands-on experience in reagent manufacturing, including handling chemical and biological materials. Knowledgeable in reagent manufacturing equipment, material management, and ISO 13485-compliant processes, with the ability to follow procedures in fast-paced environments. Assist in manufacturing and quality testing of RUO and IVD products, troubleshooting, validation planning and execution, and documentation development and revision.

Requirements

• Bachelor's degree in Biology, Molecular Biology, Genetics or related field preferred. At a minimum associate's degree in life sciences or related field; or High School Degree/General Education Diploma and 2 years of relevant experience in lieu of Bachelor’s degree.
• 1+ years of experience in a general laboratory setting through prior job experience, education, or a combination of both.
• A minimum of 0-2 years of experience in manufacturing medical devices 21CFR820 and ISO 13485, cGMP manufacturing environment preferred.
• Strong molecular biology skills; e.g. DNA/RNA purification, nucleic acids hybridization, PCR, qPCR, ddPCR.
• Critical thinking, attention to detail, and thorough record-keeping.
• Proficient in the use of Microsoft Office Excel and Word.

Nice To Haves

• Experience with NGS (preparing libraries, running NGS instruments); NGS data processing is a big plus.
• Experience with automation (e.g, Hamilton, Bravo) is a big plus.
• Experience using ERP systems such as Netsuite is a big plus.
• Ability to work independently and collaboratively with team members.
• Be flexible with tasks and schedules.
• Strong problem-solving skills with the ability to identify quality issues.
• Comfortable working in a fast-paced, high-growth company environment, with the flexibility and drive to support evolving priorities.
• Team player with excellent communication skills.
• Excellent organizational record-keeping and attention to details, effective written and verbal communication skills.
• Strong work ethic to generate high quality products under tight deadlines.

Responsibilities

• Assist with equipment qualification (IQ/OQ/PQ), PM maintenance, and basic troubleshooting of equipment.
• Perform daily maintenance and maintain records in accordance with ISO13485 requirements.
• Assist with planning and execution of validation activities.
• Support reagent stability and shelf life extension testing.
• Assist with inventory management: receive, inspect, label, and store raw materials and components, ensuring accurate lot control, FIFO usage, and traceability in accordance with inventory procedures.
• Conduct physical inventory counts, cycle counts, and material reconciliations of the raw materials, components, and finished goods.
• Maintain an accurate inventory management system.
• Prepare work orders (including material preparation, staging, line setup, and records for production), verify identity and quality of materials used for manufacturing.
• Performing tasks including reagent formulation, filling, assembly, packaging, material handling, in-process quality checks, adherence to safety protocols, accurate documentation, and support for continuous improvement initiatives.
• Print labels using control templates in Bartender or equivalent tool and ensuring adequate process controls.
• Perform manual and semi-automated operations for labeling, pipetting, and capping/sealing across tubes, 96-well plates.
• Perform clinical diagnostic reagent manufacturing in-process and lot release QC testing and data analysis.
• Assist in drafting and revising Reagent Manufacturing documentation such as SOPs, batch records, and material specifications.
• Follow standard operating procedures (SOPs) and work instructions.
• Maintain detailed and organized manufacturing records, including logs, and batch records per ISO 13485, FDA, cGMP and GDP guidelines.
• Assist in identifying, documenting, and escalating non-conformance events.
• Support root cause investigations and resolution implementation.
• May be required to perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree