Senior Manager, Reagent & Assay Development

Kelly Science, Engineering, Technology & Telecom; Atlanta (GA); On-site; USD 140,000 - 170,000; Full time

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

• Location: Northeastern suburb of downtown Atlanta, GA
• Compensation: $140,000 – $170,000 / Year (Direct Hire)

About the Role

Are you a visionary scientific leader passionate about advancing transfusion medicine and immunohematology? We are seeking a Senior Manager, Reagent & Assay Development to lead our R&D team through the full lifecycle of innovative in-vitro diagnostic (IVD) reagents and assays—from early concepts through commercialization.

In this high-impact leadership role, you will shape our technical strategy, mentor top-tier scientific talent, and drive the development of life-saving diagnostic products that enhance patient safety and clinical workflows.

Key Responsibilities

• Lead the design, optimization, and validation of core immunohematology assays and reagents, including ABO/Rh typing, antibody screening/identification, DAT/IAT assays, and automation-compatible systems.
• Build, inspire, and manage a multidisciplinary team of scientists and research associates, fostering a culture of innovation, accountability, and scientific rigor.
• Oversee cross-functional product development under strict design controls, ensuring seamless progression from feasibility through verification, validation, and manufacturing transfer.
• Partner closely with Manufacturing, Quality, Regulatory Affairs, Clinical Affairs, and Marketing to align product pipelines with regulatory standards and market demands.
• Interface with key opinion leaders, hospitals, blood centers, and external partners while presenting high-level technical updates to senior leadership.

What We’re Looking For

• Education: Ph.D., M.S., or equivalent advanced degree in Immunology, Hematology, Biochemistry, Molecular Biology, Clinical Laboratory Science, or a related field. (SBB / Specialist in Blood Banking certification is strongly preferred).
• Experience: 7+ years of progressive industry experience in IVD, biotechnology, diagnostics, or transfusion medicine.
• Leadership: Minimum of 5 years of direct people management and team leadership experience within a regulated environment.
• Technical Mastery: Deep, demonstrated expertise in immunohematology reagent formulation, antibody characterization, and serological testing methodologies.
• Regulatory Acumen: Proven track record of taking regulated IVD products from concept all the way to commercial launch under design control frameworks. Experience with automated diagnostic platforms is a major plus!

Why Join Us?

Take the next step in your career with an organization dedicated to cutting-edge diagnostics and patient care. We offer competitive compensation, comprehensive benefits, and the opportunity to make a tangible difference in global transfusion medicine.