Reagent Manufacturing Associate I

Karius • Redwood City, CA

5d • Onsite

About The Position

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.

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 preferred, including DNA/RNA purification, nucleic acid handling, PCR, qPCR, and/or related techniques.
• Strong attention to detail, willingness to follow established procedures, and commitment to accurate documentation and record-keeping.
• Ability to work independently and collaboratively with team members.
• Highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives.
• Strong problem-solving skills.
• Strong teamwork and motivation skills are essential.
• Strong organizational, record-keeping and communication (verbal and written) skills.
• Strong work ethic to generate high quality work under tight deadlines.

Nice To Haves

• Exposure to NGS workflows, reagent manufacturing, or regulated environments such as ISO 13485, 21 CFR Part 820, cGMP, and/or GDP is a plus.

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 This Job Offers

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