Manufacturing Scientist / Technical Manufacturing Specialist

Location

Irvine, CA

Full-time, on-site

Position Summary

nRichDX is seeking a highly capable Manufacturing Scientist / Technical Manufacturing Specialist to support the production of advanced liquid biopsy sample preparation kits, reagents, and related workflow components.

This role is ideal for someone with a strong scientific background, excellent technical discipline, and hands-on experience in a high-quality biotech, diagnostics, reagent, or life-science manufacturing environment.

The ideal candidate will be able to contribute immediately to Manufacturing while also having the scientific capability and flexibility to support R&D activities when needed.

Key Responsibilities

• Manufacture reagents, buffers, bead-based components, and sample preparation kits according to approved procedures and batch records.
• Support production of nucleic acid extraction kits and related workflows, including cfDNA, cfRNA/cfTNA, and CTC enrichment products.
• Prepare, aliquot, label, package, and document kit components with a high level of accuracy and consistency.
• Follow SOPs, batch records, work instructions, and internal quality requirements.
• Maintain accurate production records, equipment logs, material usage records, and manufacturing documentation.
• Perform in-process checks and support QC testing as needed.
• Troubleshoot manufacturing issues related to reagent preparation, bead handling, formulation, yield, contamination, or process variability.
• Support investigations, deviations, NCRs, CAPAs, and change-control activities when required.
• Work closely with R&D to support process transfer, new product introduction, pilot builds, and process improvements.
• Assist with experimental builds, verification studies, and technical troubleshooting when Manufacturing workload allows.
• Maintain lab cleanliness, inventory organization, and safe handling of chemicals, reagents, and biological materials.
• Contribute to continuous improvement of manufacturing workflows, documentation, and operational efficiency.

Required Qualifications

• Bachelor’s degree or higher in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a closely related scientific field.
• Minimum 3 years of hands-on experience in biotech, diagnostics, reagent, kit, pharmaceutical, or life-science manufacturing.
• Strong understanding of laboratory practices, reagent preparation, solution chemistry, and controlled documentation.
• Experience working with SOPs, batch records, controlled procedures, and quality systems.
• Excellent attention to detail and ability to follow complex protocols accurately.
• Strong organizational skills and ability to manage multiple tasks in a fast-paced environment.
• Ability to troubleshoot technical problems and communicate findings clearly.
• Comfortable working cross-functionally with Manufacturing, R&D, Quality, and Operations.

Preferred Qualifications

• Experience in molecular diagnostics, liquid biopsy, nucleic acid extraction, magnetic bead-based workflows, or sample preparation technologies.
• Experience with ISO 13485, GMP, GLP, or other regulated manufacturing environments.
• Familiarity with cfDNA, cfRNA, cfTNA, CTC enrichment, PCR, qPCR, TapeStation, Qubit, or related analytical methods.
• Experience supporting process transfer from R&D to Manufacturing.
• Ability to contribute to experimental design, process development, and data review when supporting R&D.
• Experience with inventory control, raw material qualification, incoming inspection, and manufacturing documentation.

Ideal Candidate Profile

The ideal candidate is more than a traditional manufacturing technician. We are looking for someone with a strong scientific foundation, excellent hands-on skills, and the ability to think critically.

This person should be disciplined enough to execute Manufacturing work with precision, but flexible and curious enough to support R&D when needed. The right candidate will be detail-oriented, reliable, technically strong, and comfortable working in a small-company environment where priorities can shift quickly.

Work Environment

This is a hands-on, lab-based role involving reagents, chemicals, magnetic beads, biological samples, kit components, laboratory equipment, and controlled manufacturing processes. The candidate must be comfortable following safety procedures and working in a quality-focused environment.

About nRichDX

nRichDX develops advanced sample preparation technologies for liquid biopsy and molecular testing applications. Our platforms are designed to enable high-performance extraction and enrichment of nucleic acids and rare targets from challenging biological samples.