Senior Manager, Immunohematology Reagents & Assays

Werfen; Norcross (GA); On-site; USD 180,000 - 240,000; Full time

Job summary

Werfen is seeking a Senior Manager to lead a team of scientists in the scientific and operational development of immunohematology reagents and assays from concept through commercialization.

The role manages cross‑functional development for blood grouping, antibody screening/identification, and transfusion diagnostics while ensuring regulatory and quality requirements. Leadership, project management, and commercialization experience in regulated IVD environments are essential.

Qualifications

• Ph.D., M.S., or equivalent in immunology, hematology, CLIS or related field.
• 10+ years in IVD/diagnostics or transfusion medicine industries.
• 5+ years of leadership or people management experience.
• Strong knowledge of transfusion medicine principles and serological testing.

Responsibilities

• Lead design, development, and validation of immunohematology reagents and assays.
• Oversee products including ABO/Rh typing reagents and antibody screening/identification assays.
• Drive assay performance improvements related to sensitivity, specificity, stability, reproducibility, and robustness.
• Mentor a multidisciplinary team and manage resources and schedules.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Clinical Affairs, Marketing, and Supply Chain.

Skills

Immunohematology

Assay development

Leadership

Regulatory compliance

Data analysis

Education

Ph.D./M.S. in Immunology or related field

SBB certification (preferred)

Tools

Automated diagnostic platforms

Workflow automation systems

Job description

Werfen is seeking a Senior Manager to lead a team of scientists in the scientific and operational development of immunohematology reagents and assays from concept through commercialization.

The role manages cross‑functional development for blood grouping, antibody screening/identification, and transfusion diagnostics while ensuring regulatory and quality requirements. Leadership, project management, and commercialization experience in regulated IVD environments are essential.