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.

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

Minimum Education & Experience

Education:

• Master’s degree in biological or related science required, Ph.D. degree highly preferred.

Experience:

• 10+ years’ experience leading assay development businesses in an IVD or autoimmunity regulated medical device environment required.
• 5+ years in a senior leadership position, including strategic planning, product development and developing high performing management teams required.
• Experience in autoimmunity-related diagnostic platforms such as ELISA, indirect immunofluorescence, chemiluminescence immunoasssys and multi-analyte technologies strongly preferred.
• Proven track record of taking medical device products from concept through development and successful commercialization.

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

Skills & Capabilities

• Understanding of design controls, quality system regulation and relevant regulatory requirements for the design, development and commercialization of diagnostic technologies and products.
• Experience developing budget proposals and managing to multiple budgets.
• Ability to analyze and interpret scientific data, technical journals, financial reports, government regulations and legal documents required.
• Financial acumen and aptitude (P&L, ROI, NPV, etc.) required.
• Demonstrated experience and a track record of success in leading high performing management teams required.
• Innovative mindset, unafraid to champion new ideas and technologies.
• Exceptional attention to detail and ability to perform under changing circumstances and environments.
• Superior communication, analytical and problem-solving skills.
• Ability to anticipate challenges and opportunities and gain alignment throughout the organization to drive organizational strategy.
• Ability to provide strong technical product and project leadership.
• Ability to develop and execute an effective, action-oriented plan.

Travel Requirements
10-20% travel, including international travel.

Salary $170,000 - $225,000