Senior Manager, Reagent and Assay Development

Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM) business line we research develop and manufacture customized assays and biomaterials. We operate directly in 30 countries and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe and our workforce is more than 7000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas our commitment to customers and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The 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.

Key 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.
  

Minimum 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: <5%

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.