About the Role

We are seeking a motivated Scientist or Senior NPI Scientist who will serve as a critical link between R&D teams and manufacturing. Your focus will be developing and refining methods for the production and testing of our processes, technologies, and products.

As a member of our team, you will contribute to new product scale-up, process optimization, technology transfer, and process validation activities. You will draft production procedures and product specifications for antibody reagents, and help investigate and resolve issues for smooth transfers. Our ideal candidate brings a solid understanding of antibody structure and function, together with hands-on laboratory experience in antibody conjugation and in protein expression and purification.

This position is located in San Carlos, CA and requires full-time onsite presence.

Responsibilities
• Own the transfer of newly developed biochemical reagents, proteins, antibodies and sequencing assays from R&D phase to commercial.
• Design, develop and optimize scale-up studies, improve yield, stability and robustness of complex formulations and processes.
• Author documents including SOPs, batch records, and technical reports, while ensuring compliance with quality standard.
• Conduct root-cause analysis and provide technical support to resolve production-line anomalies during pilot and production phases.
• Partnering with the R&D to help establish QC release criteria and specifications for all manufactured reagents.
• Performing hands-on laboratory and production work, including reagent formulation, conjugation, and analytical sample preparation.

Requirements
• PhD in chemistry, biochemistry, molecular biology or a related field with 2-3 years of industry experience; or an MS with 3-5 years, or a BS with 5-7+ years of relevant industry experience.
• Deep knowledge of protein biochemistry, protein purification, regent formulation or analytical chemistry (HPLC, MS, FPLC)
• Experience in BOM setup using Arena/Agile software, costing analysis, supply chain set-up, vendor management.
• Hands-on experience working in controlled development or manufacturing environment (ISO9001 & ISO 13485).
• Strong interpersonal and communication skills, with the ability to document processes clearly and help train others to execute SOPs.
• Proficiency in Excel; familiarity with project tracking tools (Smartsheet, Microsoft Project, or similar).
• Willingness to work hands-on in the lab and production environment.
• Demonstrate project management skills with an ability to meet project timelines and deliverables.