Director, Assay Development

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, budegtary constrints and regualtory requirments.
• 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 direction; works cooperatively with managers and peers
• Proven ability to work independently and as part of a team.
• Organized and detail-oriented with strong problem-solving skills.
• Committed to continuous improvement and operational excellence
• Maintain records and files of work and revisions according to procedures and processes by following cGDP.

Travel requirements:

Minimal – only as needed for meetings and conferences (5%).