Manager, R&D - Assay Feasibility

Job Summary

Join Werfen's Autoimmunity business as a Manager, R&D - Assay Feasibility where you will lead a team of research associates focused on advancing innovation in autoimmune diagnostics through biomarker discovery, assay development, and clinical autoimmunity research. Reporting to the Director of R&D, this role is responsible for driving feasibility studies, evaluating novel biomarkers, supporting assay development programs, and providing scientific leadership across cross-functional initiatives.

Management Accountabilities

• Responsible for the overall performance of assigned department(s), including a well-trained, high performing, engaged workforce.
• Management and leadership to people managers and individual contributors within assigned span of control.
• Collaborates in deciding strategies and department goals to achieve company objectives.
• Responsible for effective collaboration between assigned department and other departments and Werfen entities.
• Collaborates in managing department headcount, including recruitment, interviewing, selection, training, coaching, development, goal setting, and performance management.
• Provides input into department budgets; monitors department expenditures.
• Determines the need for new or improved processes or resources.
• Responsible for department metrics and data collection methodologies, including interpreting data to make recommendations to Department Senior Leadership.
• Manages and influences department and cross-functional projects.
• Proactively manages employee relations issues and ensures risks are identified and mitigated.
• Promotes a culture that supports compliance with applicable SOPs, ISO, FDA and other Quality System Regulations.

Research & Development Accountabilities

• Collaborates in research & development operations to identify and develop best in class products for autoimmune diseases and related conditions.
• Includes all activities related to identification of new biomarkers and development of products within assigned area(s).
• Participates in successful collaboration with external organizations (KOLs, customers, etc.) and other Werfen entities.
• Manages technical issues, root cause corrective action analysis, customer complaint investigation support, design of experiments, new product technology transfer support, and supplier technical assistance.
• Oversees specification, selection, vendor contacts, installation, documentation, validation and training for new equipment.
• Participates in scientific meetings and exhibitions and reports on new trends in autoimmunity research fields.
• Facilitates the improvement of products by investigating formulation changes or manufacturing procedures.
• Maintains knowledge of academic and commercial technology trends and competitive developments.

Qualifications

• Bachelor's degree in biology or other life sciences related field required. Masters degree preferred.
• A minimum of 10 years of experience within a regulated medical device environment required, preferably in IVD or autoimmunity.
• Experience in different diagnostic platforms, such as ELISA, indirect immunofluorescence (IFA), and/or multi-analyte technologies preferred.
• Proven track record of taking medical device products from inception through development and successful commercialization.
• At least 5 years of experience managing and developing junior level management staff required.
• Proven track record of building and managing successful business operations and high performing teams required.
• Deep understanding of design control procedure, quality system regulations and relevant regulatory requirements.
• Strong understanding of life sciences related compliance requirements (e.g., US QSRs, EU IVDR, ISO 13485, ISO 14971).
• Ability to analyze and interpret scientific data, technical journals, financial reports, and government regulations required.
• Advanced ability to constructively prevent and resolve conflicts.
• Critical thinking capability and decision making.
• Strong influencing and negotiation skills.