Director, Assay Development

Overview

Job Summary

The Director of Assay Development, within Autoimmunity’s (AID) Research & Development function, oversees the entire reagent lifecycle of assay development, from concept through commercialization and on-market support. Position is responsible for designing, validating, and optimizing autoimmunity-based assays, ensuring they meet the highest standards of performance and regulatory compliance. This role requires deep knowledge of autoimmunity, biotechnology, quality & regulatory requirements, strategic leadership, and excellence in developing management staff and high performing teams. As a senior member of the R&D leadership team, this position is responsible for overall management and leadership of Autoimmunity’s assay development business planning and operations management. Ensure all work is carried out in accordance with the Autoimmunity’s Quality Management System.

Responsibilities

Key Accountabilities

 

Leadership and Team Management:

• Develops and provides strategic direction to AID’s assay development team, fostering a culture of collaboration, innovation, and continuous improvement.
• Ensures effective management and collaboration of internal staff, external collaborators, and third-party vendors to lead the successful design, development and optimization of assays.
• Mentors and develops people managers and individual contributors, instilling excellence in bench skills, scientific thought, technical writing, and project management.
• Role models Werfen Values in the quality of work and working relationships. Strategic Planning:
• Serves as the subject matter expert for assay design and development for Autoimmunity, advising senior leadership on strategic initiatives to enhance assay products and services.
• Collaborates with Marketing, Quality Systems, Product Management and other stakeholders to define assay development goals and roadmaps that align with overall business objectives.

Assay Design, Development and On-Market Support:

• Leads the design and optimization of autoimmunity-based assays, to ensure high quality products, scientific procedures, quality standards and efficient business practices.
• Ensures assay development is conducted with rigorous adherence to Design Control practices, following Autoimmunity’s Quality Management System (QMS).
• Ensures thorough documentation of development processes, experimental results, and data analyses to support internal decision-making and regulatory submissions.
• Ensures robostness of assays and facilitates design transfer to other departments including, but not limited to Manufacturing, Qualty Systems, Regulatory Affairs and Marketing.
• Leads on-market efforts for escalated complaints and analyzes need to design changes through the product change request (PCR) process.
• Serves as the R&D representative on core teams. Where appropriate, acts as the core team leader on product development projects.

Technical Excellence and Innovation:

• Stays abreast of emerging technologies and industry trends in autoimmunity diagnostics to drive innovation and continuous improvement in assay development.
• Partners with the Quality team to establish and maintain robust quality systems and standard operating procedures ensuring the highest standards of assay performance and reliability.
• Fosters partnerships with external collaborators, academic institutions, and industry experts to enhance Werfen’s assay development capabilities.

Resource Management:

• Plans, presents and manages department budgets, resource allocation, and project timelines to optimize leadership of AID’s assay development business.
• Recruits, onboards, and retains top-tier talent, building a strong and dynamic team committed to advancing Werfen’s purpose of Powering Patient Care.
• Responsible for workforce planning to ensure positions and teams are structured to optimize resources and achieve company goals.
• Ensures staff comply with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), Standard Work (SW), Quality Management System (QMS) regulations, as well as Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.Networking/Key Relationships

• AID R&D teams
• AID Quality, Regulatory & Compliance teams
• AID Marketing & Service teams
• AID Manufacturing teams
• AID Finance team

Qualifications

Minimum Education & Experience

 

Education:

• Master’s degree in bi