Director, Immunoassay Development
Core
Provide scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials supporting immunoassays across the vaccine pipeline.
Role type
Director, Immunoassay Development (CMC/Analytical)
Builds
High-fidelity vaccines targeting bacterial diseases (e.g., pneumococcal, Group A Strep, Shigella)
Domain
Biopharmaceuticals / Vaccine Development / Clinical Stage
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Immunoassay method development, ligand-binding assay expertise, GMP/GLP compliance, CMC execution, laboratory team leadership, assay troubleshooting, validation strategy, outsourcing management, regulatory documentation
Preferred skills
Experience with MSD platforms, automation-enabled workflows, cross-functional technical workstream leadership
Technologies
ELISA, MSD, ligand-binding assays, automation workflows
Responsibilities
Establish and scale the Immunoassay capability within the CMC group; provide daily laboratory leadership including experimental planning and instrument oversight; build and mentor a team of scientists; develop fit-for-purpose immunoassays for potency, identity, and stability; lead troubleshooting and root-cause analysis; evaluate and implement innovative assay technologies; oversee outsourced immunoassay activities with CROs and vendors; support method validation and regulatory submissions; manage resources and timelines across multiple projects.
Seniority
Director, strategic leadership with hands-on technical execution
