Senior Manager, 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
Senior Manager, Immunoassay Development
Builds
Critical reagents, reference materials, and immunoassay platforms for vaccine CMC programs
Domain
Biopharmaceuticals / Vaccine Development / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Immunoassay development and optimization, Ligand-binding assay platforms (ELISA, MSD, bead-based, multiplex), Laboratory operations management, Team leadership and staff development, Method transfer and validation support, Analytical control strategy execution, CRO/CDMO management, Data review and documentation oversight
Preferred skills
PhD in Biochemistry, Immunology, or Analytical Chemistry, Experience in regulated analytical environments (QC, ASAT), Hands-on troubleshooting experience
Technologies
ELISA, MSD, electrochemiluminescence, bead-based assays, multiplex assays
Responsibilities
Manage daily immunoassay laboratory operations including study scheduling and staff planning, Lead and mentor scientists on immunoassay development and lifecycle management, Assign and prioritize laboratory work based on program needs, Provide technical oversight for assay execution and data integrity, Support evaluation of innovative immunoassay platforms and technologies, Coordinate routine analytical testing and GMP-supporting activities, Manage outsourced immunoassay activities with external partners, Develop staff capability through coaching and training
Seniority
Senior Manager, hands-on IC with people leadership