Senior Lead, Immunohematology Reagent & Assay Development

Myadlm; Norcross (GA); Presencial; USD 140 000 - 190 000; Tempo integral

Resumo da oferta

Werfen is seeking a Senior Manager, Reagent & Assay Development to lead a team of scientists in immunohematology R&D from concept to commercialization. The role oversees ABO/Rh typing, antibody screening/identification, DAT/IAT, and rare antigen reagents, ensuring regulatory and quality compliance.

The ideal candidate brings deep immunohematology expertise, strong leadership, and commercialization experience within regulated IVD environments, with a track record of delivering cross-functional

Qualificações

• Ph.D., M.S., or equivalent advanced degree in Immunology, Hematology, Clinical Laboratory Science, Biochemistry, Molecular Biology, or related discipline.
• SBB certification strongly preferred.
• 10+ years of experience in IVD, biotech, diagnostics, or transfusion medicine industries.
• 5+ years of leadership or people management experience.
• Demonstrated expertise in immunohematology assay and reagent development.
• Experience developing regulated IVD products from concept to commercialization.

Responsabilidades

• Lead the design, development, optimization, and validation of immunohematology reagents and assays for transfusion diagnostic applications.
• Oversee development activities for products including ABO/Rh typing reagents, antibody screening/identification, DAT/IAT, rare antigen detection, and automation-compatible systems.
• Drive assay performance improvements in sensitivity, specificity, stability, reproducibility, and robustness.
• Establish strategies for reagent formulation, antibody characterization, antigen sourcing, and assay controls.
• Evaluate emerging technologies applicable to immunohematology diagnostics.
• Provide technical leadership during troubleshooting and product performance evaluations.
• Build, mentor, and lead a multidisciplinary team of scientists and research associates.
• Set departmental goals, priorities, and performance metrics.

Conhecimentos

Immunohematology

Assay Development

Leadership

Project Management

Regulated IVD

Formação académica

PhD or MS

SBB Certification

Descrição da oferta de emprego

Werfen is seeking a Senior Manager, Reagent & Assay Development to lead a team of scientists in immunohematology R&D from concept to commercialization. The role oversees ABO/Rh typing, antibody screening/identification, DAT/IAT, and rare antigen reagents, ensuring regulatory and quality compliance.

The ideal candidate brings deep immunohematology expertise, strong leadership, and commercialization experience within regulated IVD environments, with a track record of delivering cross-functional