Director, Assay Development

Introduction

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.

Overview

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.

Responsibilities

Key Accountabilities

 

Leadership & Strategy

• Lead the assay and product development teams, providing scientific and technical guidance.
• Create a culture of design control princples 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.

Assay and Product Development

• 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.

Project Management

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

Regulatory & Quality Compliance

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

Team Development

• Mentor and develop scientific staff on design of experiements 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.

 

Networking/Key relationships

 

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

Qualifications

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 priortize and manage multple workloads efficiently
• Intermediate proficiency in Microsoft Office (Word, Excel) and specialized systems (TrackWise, MasterControl, SharePoint).
• Receptive to feedback and directi