Director, Assay Development

About the Position

Werfen

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 7,000 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. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

Responsible for the strategic planning for the assay development and product development teams to align with corporate objectives. This position will lead the discovery, design, development, and optimization of diagnostic products and assays for our IVD product portfolio. This role will oversee teams to drive innovation in transfusion diagnostics to meet clinical needs and regulatory requirements.

• Lead the assay and product development teams, providing scientific and technical guidance.
• Create a culture of design control principles focused on developing state of the art products with the highest degree of quality.
• Develop and execute strategic plans for assay and product development aligned with company goals.
• Collaborate with executive leadership to define product development roadmaps.

• Oversee the discovery, design, optimization, and feasibility of serological, molecular, immunohematology products and assays.
• Ensure robustness, reproducibility, and scalability of assays for clinical and commercial use.
• Evaluate and implement new technologies and platforms to enhance assay performance to meet clinical needs.

• Develop and execute project plans, ensuring adherence to timelines, budgetary constraints and regulatory requirements.
• Foster a culture of innovation within the assay development team.

• Establish and maintain robust design processes to ensure the reliability and accuracy of diagnostic assays.
• Collaborate with regulatory affairs to ensure compliance with relevant industry standards and regulations.

• Mentor and develop scientific staff on design of experiments and data analysis, fostering a culture of innovation and excellence.
• Focus on potential patent and publication opportunities for the team.
• Recruit and retain top talent in assay development and related disciplines.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Key cross functional relationships with other R&D teams, Manufacturing, Marketing, Regulatory and Quality.

Minimum Knowledge & Experience required for the position:

• Ph.D. or Master's degree in Biochemistry, Molecular Biology, Immunology, or related field.
• Minimum of 10 years of experience in assay and product development within the IVD or life sciences industry.
• Proven leadership experience managing scientific teams and complex projects.
• Deep understanding of assay technologies (e.g., ELISA, PCR, NGS, etc).
• Strong knowledge of regulatory requirements for IVD products.
• Excellent communication, organizational, and problem-solving skills.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Strong verbal and written communication skills specifically related to complex biological concepts and technical documentation.
• Effective collaborator across departments and with cross-functional teams.
• Demonstrates ability to prioritize and manage multiple workloads efficiently.
• Intermediate proficiency in Microsoft Office (Word, Excel) and specialized systems (Track Wise, Master Control, SharePoint).
• Receptive to feedback and direction; works cooperatively with managers and peers.
• Proven ability to work independently and as part of a team.
• Organized and detail-oriented with strong problem-solving skills.
• Committed to continuous improvement and operational excellence.
• Maintain records and files of work and revisions according to procedures and processes by following cGDP.

Travel requirements:

Minimal - only as needed for meetings and conferences (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…