Senior Scientist, Immunoassay Development, Critical Reagents & Reference Materials (Biotech)

Location: San Carlos, California, United States; onsite at least 4 days per week

Salary: $165,000–$193,000 per year in the San Francisco Bay Area, plus benefits and equity.

Company

hirify.global develops vaccine products and analytical methods supported by immunoassay development and critical reagent programs.

What you will do

• Lead monoclonal antibody generation, screening, characterization, qualification, stability assessment, bridging, and lifecycle management studies.
• Develop characterization strategies covering specificity, affinity, cross-reactivity, epitope behavior, assay performance, stability, and lot-to-lot comparability.
• Manage reference standards, assay controls, calibrators, customized MSD plates, coated plates, labeled detection reagents, multiplex components, assay kits, and other critical materials.
• Design and execute stability programs, including protocols, storage conditions, timepoints, acceptance criteria, trend analysis, expiry or retest dating, and reporting.
• Establish qualification and bridging strategies and manage inventory, chain of custody, replenishment, and lifecycle documentation.
• Oversee CRO, CDMO, contract laboratory, vendor, and technology partner activities, while supporting immunoassay development, troubleshooting, method transfer, validation readiness, and GMP-supporting testing.

Requirements

• PhD in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related field with at least 5 years of relevant biopharmaceutical industry experience; alternatively, an MS with 10 years or a BS with 13 years of relevant experience.
• Hands-on experience with monoclonal antibody generation and characterization is required.
• Experience with antibody reagent generation, screening, qualification, conjugation, labeling, lot bridging, stability assessment, and lifecycle management.
• Experience managing critical reagents, reference standards, assay controls, calibrators, and customized materials for ligand-binding assays or vaccine analytical methods.
• Hands-on experience with ELISA, MSD, electrochemiluminescence, bead-based, multiplex, or other ligand-binding assay platforms.
• Experience with antibody-antigen interactions, reagent quality attributes, matrix effects, comparability, stability, and outsourced biopharmaceutical activities.

Nice to have

• Experience in GMP-regulated analytical environments and with materials used for GMP release and stability testing.
• Experience with antibody engineering, recombinant antibody production, hybridoma generation, purification, biotinylation, ruthenium or fluorescent labeling, bead conjugation, or multiplex panel design.
• Experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics.
• Experience developing reagent history files, lifecycle plans, stability and bridging protocols, inventory systems, and replenishment strategies.

Culture & Benefits

• Onsite collaboration in San Carlos with a minimum of four onsite days per week.
• Comprehensive employee benefits.
• Equity component included in the compensation package.
• Work with internal teams and external scientific and technology partners across the vaccine development pipeline.