OverviewJob SummaryThe Senior Manager, Reagent & Assay Development will lead a team of scientists in the scientific and operational development of immunohematology in-vitro diagnostic (IVD) reagents, assays, and supporting technologies from concept through commercialization. This role is responsible for managing cross-functional development activities related to blood grouping, antibody screening/identification, compatibility testing, and transfusion diagnostics while ensuring compliance with applicable regulatory and quality requirements.
The ideal candidate combines deep technical expertise in immunohematology and assay development with strong leadership, project management, and commercialization experience within regulated IVD environments.
ResponsibilitiesKey Accountabilities- 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 and identification assays
- DAT/IAT assays
- Rare antigen detection reagents
- Automation-compatible reagent systems
- Drive assay performance improvements related to sensitivity, specificity, stability, reproducibility, and robustness.
- Establish scientific strategies for reagent formulation, antibody characterization, antigen sourcing, and assay controls.
- Evaluate emerging technologies and methodologies applicable to immunohematology diagnostics.
- Provide technical leadership during troubleshooting, root cause investigations, and product performance evaluations.
- Build, mentor, and lead a multidisciplinary team of scientists and research associates.
- Establish departmental goals, development priorities, and performance metrics.
- Foster a collaborative, innovative, and quality-focused culture.
- Manage resource allocation, staffing plans, budgets, and external partnerships.
- Lead projects through the full product lifecycle from feasibility through verification, validation, transfer to manufacturing, and post-market support.
- Ensure adherence to design control requirements and stage-gate development processes.
- Collaborate with Manufacturing, Quality, Regulatory Affairs, Clinical Affairs, Marketing, and Supply Chain teams.
- Support technology transfer and manufacturing scale-up activities.
- Performs other duties and responsibilities as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships- Partner with clinical and commercial teams to align product development with customer and market needs.
- Interface with key opinion leaders, blood centers, hospitals, and external collaborators.
- Present technical updates to senior leadership and external stakeholders.
QualificationsMinimum Knowledge & Experience required for the position:- Ph.D., M.S., or equivalent advanced degree in Immunology, Hematology, Clinical Laboratory Science, Biochemistry, Molecular Biology, or related scientific discipline preferred.
- SBB (Specialist in Blood Banking) 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.
- Strong knowledge of transfusion medicine principles and serological testing methodologies.
- Experience with automated diagnostic platforms preferred.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:- Deep understanding of: Immunoassay technologies and techniques, Red cell serology, Monoclonal and polyclonal antibody technologies, Reagent formulation and stabilization Assay verification and validation, Statistical data analysis and experimental design.
- Familiarity with analytical performance studies including precision, interference, sensitivity, specificity, and stability testing.
- Knowledge of risk management principles and usability engineering is preferred.
- Experience supporting FDA submissions and international regulatory approvals.
- Knowledge of blood bank automation systems and workflow integration.
- Experience working with global development or manufacturing teams.
- Track record of innovation and successful product launches in immunohematology diag-nostics.
Travel requirements:Minimal Travel Required:
