Senior Manager, Immunoassay & Reagent Development Lead

Kelly Science, Engineering, Technology & Telecom

Atlanta (GA)

On-site

USD 140,000 - 170,000

Full time

8 days ago

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Job summary

Senior Manager, Reagent & Assay Development leads the R&D team through the full lifecycle of in-vitro diagnostic reagents and assays, including ABO/Rh typing, antibody screening, and automated systems. The role shapes technical strategy, mentors scientists, and drives product development from concept through commercialization.

The position requires a Ph.D./MS in a related field, 7+ years in IVD/biotech, and 5+ years of leadership in a regulated environment.

Qualifications

  • Ph.D., M.S. or equivalent in a relevant field with related certification preferred.
  • 7+ years in IVD/biotech/transfusion medicine.
  • 5+ years of direct people management in a regulated environment.

Responsibilities

  • Lead design, optimization, and validation of immunohematology assays and reagents.
  • Build and lead a multidisciplinary team of scientists and research staff.
  • Oversee cross-functional development under design controls from feasibility to manufacturing transfer.
  • Partner with Manufacturing, Quality, Regulatory, Clinical, and Marketing to align products with regulatory and market needs.
  • Interface with hospitals, blood centers, and external partners while reporting to senior leadership.

Skills

Immunohematology
IVD industry experience
Leadership
Regulatory knowledge
Product development

Education

Ph.D./M.S. in Immunology or related field
M.S. or equivalent advanced degree
SBB / Specialist in Blood Banking

Job description

Senior Manager, Reagent & Assay Development leads the R&D team through the full lifecycle of in-vitro diagnostic reagents and assays, including ABO/Rh typing, antibody screening, and automated systems. The role shapes technical strategy, mentors scientists, and drives product development from concept through commercialization.

The position requires a Ph.D./MS in a related field, 7+ years in IVD/biotech, and 5+ years of leadership in a regulated environment.

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