Senior Manager, Reagent and Assay Development
About The Position
The Senior Manager, Reagent & Assay Development leads 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. The role manages cross-functional development activities related to blood grouping, antibody screening and identification, compatibility testing, and transfusion diagnostics, while ensuring compliance with applicable regulatory and quality requirements. The position provides technical and organizational leadership across product development, including reagent and assay design, optimization, validation, performance evaluation, and troubleshooting. It oversees the full product lifecycle from feasibility through verification, validation, transfer to manufacturing, and post-market support, and works closely with internal functions and external collaborators to align development with customer and market needs.
Requirements
- Ph.D., M.S., or equivalent advanced degree in Immunology, Hematology, Clinical Laboratory Science, Biochemistry, Molecular Biology, or a related scientific discipline preferred; relevant work experience may be substituted at management’s discretion.
- 10 or more years of experience in IVD, biotech, diagnostics, or transfusion medicine industries.
- 5 or more 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.
- 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.
- 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 diagnostics.
- Minimal travel required: less than 5%.
Nice To Haves
- SBB (Specialist in Blood Banking) certification is strongly preferred.
- Experience with automated diagnostic platforms.
- Knowledge of risk management principles and usability engineering.
Responsibilities
- Lead the design, development, optimization, and validation of immunohematology reagents and assays for transfusion diagnostic applications.
- Oversee development of ABO/Rh typing reagents, antibody screening and identification assays, DAT/IAT assays, rare antigen detection reagents, and automation-compatible reagent systems.
- Drive assay performance improvements in 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, and foster a collaborative, innovative, quality-focused culture.
- Manage resource allocation, staffing plans, budgets, and external partnerships.
- Lead projects through the product lifecycle from feasibility through verification, validation, manufacturing transfer, 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.
- 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.
- Perform other duties and responsibilities as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
