Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office

Job Description

The job:

Thermo Fisher Scientific’s 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, you'll guide the teams developing advanced solutions that enable our customers to make the world healthier, cleaner, and safer. You'll establish strategic direction for R&D initiatives while cultivating a culture of scientific excellence and collaboration. Working closely with cross-functional partners, you'll oversee the full development lifecycle of IVD immunoassay from concept through commercialization, ensuring successful delivery of effective solutions.

You'll 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

What’s 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.