Senior Manager, Immunoassay Development (Biotechnology)

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

Salary: $170,000–$200,000 per year in the San Francisco Bay Area, plus benefits and equity

Company

hirify.global develops vaccine and biopharmaceutical products supported by CMC and analytical development capabilities.

What you will do

• Lead daily immunoassay laboratory operations, including study scheduling, staff planning, assay execution, sample and reagent readiness, instrument coordination, data review, and issue escalation.
• Manage, mentor, and develop scientists and research associates working on immunoassay development, optimization, testing, qualification support, validation readiness, and lifecycle management.
• Support fit-for-purpose immunoassays for potency, antigenicity, identity, impurity, characterization, comparability, release, and stability activities across the vaccine pipeline.
• Evaluate and support ELISA, MSD, electrochemiluminescence, bead-based, multiplex, and automation-enabled assay platforms.
• Coordinate outsourced activities with CROs, CDMOs, contract laboratories, reagent vendors, and technology partners, including timelines, data review, and deliverables.
• Partner with analytical, quality, regulatory, process development, manufacturing, clinical serology, and program management functions on transfers, validation readiness, and lifecycle strategy.

Requirements

• PhD with at least 8 years, MS with at least 13 years, or BS with at least 16 years of relevant biopharmaceutical industry experience.
• Significant hands-on experience developing, optimizing, troubleshooting, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated environments.
• Demonstrated experience leading laboratory staff, managing daily operations, assigning work, reviewing data, and developing team capability.
• Strong experience with ligand-binding immunoassay platforms, particularly ELISA, MSD, electrochemiluminescence, bead-based, or multiplex assays.
• Experience with method development, transfer, qualification, validation support, routine testing, analytical control strategies, comparability, critical reagent qualification, and reference material qualification.
• Ability to work onsite in San Carlos, California, at least four days per week.

Nice to have

• Experience with MSD, multiplex assays, automation, high-throughput workflows, LIMS, ELN, and digital data analysis tools.
• Direct experience with vaccines, conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or complex biologics.
• Experience supporting GMP environments, late-stage development, PPQ readiness, BLA preparation, commercial readiness, or lifecycle management.
• Experience scaling analytical capabilities or laboratory teams in a growing organization.

Culture & Benefits

• Comprehensive benefits package.
• Equity component included in compensation.
• Laboratory culture centered on scientific rigor, accountability, collaboration, data integrity, safety, and continuous improvement.
• Opportunities to provide coaching, technical guidance, and career development for laboratory staff.