Research & Technology Manager

Research & Technology Manager page is loaded## Research & Technology Manager remote type:
Hybrid locations:
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Full time posted on:
Posted Yesterday job requisition :
R-25832

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

As Director, Assay Development for Syva, you will lead a multidisciplinary team responsible for the development, commercialization, and lifecycle management of Siemens Healthineers’ Syva drug testing immunoassay portfolio. You will drive innovation, efficiency, and regulatory excellence, ensuring our solutions meet the highest standards for global market access and support both direct and OEM business models.
** Product Lifecycle Management & Technical Oversight
*** Lead new product development (NPD) for immunoassays under FDA Design Control (21 CFR 820) and Siemens Healthineers quality systems while ensuring Product Delivery Excellence.
* Oversee assay development activities at the Glasgow, DE site and coordinate with other international R&D sites as needed, ensuring harmonized quality and documentation standards.
* Lead development and validation activities to meet US (FDA) and international (e.g., CE-IVDR, China NMPA, etc) regulatory requirements, ensuring global market readiness.
* Ensure all assays and supporting data packages meet the requirements for OEM supply agreements and seamless integration into third-party platforms.
* Lead the technical maintenance and enhancement of commercial products, managing complex change controls and providing high-level troubleshooting for manufacturing and quality issues (CAPA/NC) as needed.
** Partnership Management
*** Work closely with our OEM-Out Business Team, negotiating technical specifications, managing deliverables, and ensuring successful implementation of Syva products with OEM customers.
* Act as the primary technical interface for strategic development partners, negotiating technical specifications, managing deliverables, and ensuring successful technology transfer for new and existing products.
** Process Optimization & Cultural Transformation
*** Champion Lean R&D principles to accelerate development cycles and increase efficiency within a regulated environment.
* Mentor and inspire teams to foster a culture of accountability, speed, scientific rigor, and collaboration across global R&D sites.
* Establish and track key performance indicators (KPIs) for the Syva assay development pipeline, providing actionable insights to executive leadership.
** Required Knowledge, Skills, and Experience
*** Ph.D. in Chemistry, Biochemistry, Clinical Chemistry, or related field (or Bachelor’s/Master’s with significant relevant experience).
* Minimum 10 years’ progressive experience in immunoassay development within IVD or clinical diagnostics.
* At least 5 years’ experience managing technical teams, including globally dispersed teams or external partners/OEMs.
* Proven track record in leading the development and launch of FDA-cleared/approved and CE-marked clinical immunoassays.
* Experience in drugs of abuse testing, toxicology, therapeutic drug monitoring, and validity testing preferred.
* Demonstrated success as a change agent in optimizing R&D processes and improving team culture.
** Your Attributes & Expectations
*** Demonstrated leadership with strong solution orientation and strategic thinking.
* Technical expertise across a broad range of assay disciplines, with the ability to explore and implement new technologies.
* Flexibility to adapt to changing business priorities and lead teams through change.
* Commitment to fostering a safe, inclusive, and high-performing laboratory and office environment.
* Strong collaboration skills, partnering with Marketing, Regulatory, Manufacturing, Project Management, Quality, and Service functions.
* Dedication to team development through training, mentoring, and recognition.
** Who we are**:
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