Director of R&D, Allergy

Work Schedule

Environmental Conditions

Job Description

The job:

Thermo Fisher Scientifics R&D Allergy department provides end-to-end scientific leadership for our Allergy in vitro diagnostic (IVD) assay portfolio spanning development lifecycle management and continuous improvement. Operating within a regulated global environment (IVDR FDA 21 CFR 820 ISO 13485) the team delivers clinically robust analytically sound and commercially sustainable diagnostic solutions.

As Director of R&D youll guide the teams developing advanced solutions that enable our customers to make the world healthier cleaner and safer. Youll establish strategic direction for R&D initiatives while cultivating a culture of scientific excellence and collaboration. Working closely with cross-functional partners youll oversee the full development lifecycle of IVD immunoassay from concept through commercialization ensuring successful delivery of effective solutions.

Youll support and develop teams of scientists engineers and technical experts while maintaining strong connections across the organization to advance innovation and technological progress. This role offers the opportunity to contribute to scientific discovery through leadership of research programs and development of transformative products.

This role is fully office-based at our Uppsala Sweden site with the flexibility to work from home 1 day per week. Some international travel will be required up to 25% of working time including overnight stays.

What will you do

Strategic & Portfolio Leadership

• Define and execute assay development strategy aligned with portfolio and innovation roadmaps
• Prioritize programs and allocate resources across innovation lifecycle management and regulatory commitments
• Contribute to lifecycle planning (line extensions upgrades cost optimization portfolio rationalization)

Assay Development Execution

• Lead end-to-end assay development: feasibility design risk analysis verification and validation
• Drive research on allergens and allergen components including sourcing characterization standardization and selection to support robust assay design and performance.

Regulatory & Quality Compliance

• Ensure compliance with IVDR FDA 21 CFR 820 ISO 13485 and applicable regulations
• Oversee DHF technical documentation risk management activities and regulatory submissions (with RA)
• Ensure audit readiness and effective CAPA execution

Sustaining Engineering & Lifecycle Management

• Provide technical oversight of post-market surveillance and performance monitoring
• Lead investigations into complaints trends and field issues; ensure timely root cause analysis and corrective actions
• Address assay variability stability raw material changes and manufacturing deviations
• Support supplier changes material obsolescence management and supply continuity

People & Organizational Leadership

• Build and develop high-performing R&D teams
• Foster a culture of scientific rigor accountability and continuous improvement
• Develop succession pipelines and technical career paths
• Operate effectively within a global matrixed organization

Cross-Functional & External Collaboration

• Partner with Product Innovation Marketing Quality & Regulatory and Medical Affairs to translate customer needs into product requirements
• Collaborate with Clinical Affairs on validation strategies and studies
• Engage with external partners academic collaborators and suppliers
• Represent R&D in governance forums and executive reviews

Who we are looking for:

• Advanced Degree in Immunology Biochemistry Molecular Biology Biomedical Engineering or related field
• Many years of experience in IVD assay development
• Experience managing managers and managing budget
• Demonstrated success delivering innovative products from concept through commercialization
• Experience with stage-gate product development processes
• Deep expertise in relevant technical domains (e.g. diagnostics biologics instrumentation)
• Strong understanding of quality systems and regulatory requirements (FDA ISO GMP)
• Experience managing complex projects budgets and resources
• Effective communication and presentation skills
• Demonstrated ability to influence and collaborate across functions
• Strategic mindset with strong business acumen
• Strong project management and organizational skills
• Strong problem-solving and analytical capabilities
• Proficiency in English required; Swedish preferred; additional languages beneficial

Whats in it for you:

We offer competitive remuneration an annual incentive plan bonus scheme and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.