Senior Manager, Reagent & Assay Development

Senior Manager, Reagent & Assay Development

• Location: NE 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

• Scientific & Technical Direction: 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.
• Team Leadership & Mentorship: Build, inspire, and manage a multidisciplinary team of scientists and research associates, fostering a culture of innovation, accountability, and scientific rigor.
• Lifecycle & Project Management: Oversee cross-functional product development under strict design controls, ensuring seamless progression from feasibility through verification, validation, and manufacturing transfer.
• Cross-Functional Collaboration: Partner closely with Manufacturing, Quality, Regulatory Affairs, Clinical Affairs, and Marketing to align product pipelines with regulatory standards and market demands.
• Strategic Networking: 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.

Ready to lead the future of immunohematology diagnostics? Apply today!

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