Director, Assay Development

Overview

The Director of Assay Development is responsible for overseeing the entire reagent lifecycle of assay development within Transfusion’s R&D Reagent Development group. The role designs, validates, and optimizes immunohematology assays, ensuring they meet high performance and regulatory standards. As a senior R&D leader, the director manages the assay development team, aligns with the Quality Management System, and drives strategic initiatives.

Responsibilities

• Develop strategic direction for the assay development team, fostering collaboration and continuous improvement.
• Manage collaboration with internal staff, external partners, and third‑party vendors to lead assay design and optimization.
• Mentor and develop managers and contributors, supporting technical and project management skills.
• Lead assay design and development, ensuring adherence to Design Control practices under the QMS.
• Document development processes, experimental results, and data analyses to support decision‑making and regulatory submissions.
• Facilitate robust assays and design transfer to Manufacturing, Quality Systems, Regulatory Affairs, and Marketing.
• Lead on‑market efforts for escalated complaints, managing change control processes.
• Act as R&D representative on core teams and, where appropriate, as core team leader on product development projects.
• Stay current on emerging technologies and industry trends in immunohematology diagnostics to drive innovation.
• Partner with Quality to maintain robust SOPs and quality systems.
• Develop resource plans, budgets, and project timelines to optimize assay development operations.
• Recruit, onboard, and retain top talent, building a dynamic and high‑performing team.
• Ensure staff comply with SOPs, WIs, SW, QMS, EHS, HR, and other regulatory policies.
• Maintain key relationships with Transfusion R&D, Quality, Regulatory & Compliance, Marketing & Service, Manufacturing, and Finance teams.

Qualifications

Minimum Education & Experience

• Master’s degree in biological or related science required; Ph.D. highly preferred.
• 10+ years of experience leading assay development in an IVD medical device environment.
• 5+ years in senior leadership roles, including strategic planning, product development, and team building.
• Experience with immunohematology diagnostic platforms and other assay technologies (ELISA, fluorescent assays, chemiluminescent, bead‑based, multi‑analyte). Molecular biology experience is a plus.
• Track record of moving medical device products from concept through commercialization.

Skills & Capabilities

• Deep understanding of design controls, quality system regulation, and regulatory requirements.
• Budget development and multi‑budget management experience.
• Strong analytical skills to interpret scientific data and regulatory documents.
• Financial acumen (P&L, ROI, NPV) and decision‑making ability.
• Proven leadership of high‑performing management teams.
• Innovative mindset and willingness to champion new technologies.
• Exceptional attention to detail and ability to work under changing circumstances.
• Excellent communication, analytical, and problem‑solving skills.
• Strategic thinking and ability to align across the organization.
• Technical product and project leadership capabilities.
• Execution of action‑oriented plans.

Travel Requirements

10‑20% travel, including international travel.

Work Environment

The position requires routine communication, data analysis, and laboratory work. Physical demands include standing or walking up to 8 hours per day, sitting up to 8 hours, handling equipment, lifting up to 25 pounds, and typical office noise levels.

Equal Opportunity Statement

Werfen is an Equal Opportunity employer committed to diversity and inclusion. Accommodations for disabilities are available upon request.

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