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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

The Lead Business Architect for Digital Laboratory Role 

The Lead Business Architect is responsible for managing a team of Architects which design and development digital laboratory target architecture.  

Thia position will be Managing our Digital Labs, remaining technically hands-on and managing a team of Digital Architects. You will be developing the execution of digital laboratory strategies in alignment with the broader digital transformation goals of our Life Sciences organization. This role is responsible for managing a team of Architects focused on designing scalable, compliant, and future-ready digital lab ecosystems—including LIMS, ELN, and lab automation systems—that support GxP operations and scientific innovation. 

The ideal candidate brings deep expertise in systems integration, laboratory informatics, and regulatory compliance (e.g., CFR Part 11, Part 58), with a passion for enabling paperless operations and real-time data-driven decision making across production, QC, and manufacturing laboratories. 

Location

This position can be based in Burlington (MA), USA or in Darmstadt, Germany.

Key Responsibilities 

 A. Leadership & Team Management 

Lead, develop, and coach a team of Digital Laboratory Architects focused on Life Sciences laboratory applications. 

Foster a high-performing team culture with strong collaboration across IT, OT, QA, laboratory operations, and regulatory functions. 

Ensure that architects are fully aligned with scientific and business goals across the ISCO domain of quality, production, and service laboratories. 

B. Digital Laboratory Architecture Design 

Oversee the creation and governance of end-to-end digital laboratory target architectures across GxP environments, ensuring data integrity, system interoperability, and adherence to global standards. 

Guide architecture strategy for platforms such as LIMS, ELN, LES, CDS, and testing services with a focus on scalability, reusability, sustainability, and compliance. 

Ensure roadmaps for laboratory systems are aligned with business needs, digital initiatives, and product lifecycle timelines. 

C. Integration and Data Flow Optimization 

Direct the design of integrated data and process flows between enterprise laboratory systems (LIMS or LES) and other enterprise systems (e.g., MES, ERP, SFDC, etc.) where appropriate. 

Oversee mapping of data pipelines from instruments to systems such as LIMS, ELN, and scientific data platforms (e.g., Uptimize), enabling a connected and automated laboratory. 

Ensure alignment with ISA-95 models, from Level 0 (equipment) to Level 4 for smart/digital lab initiatives. 

D. Demand Management 

Oversee and assign to Architects the review of demands to determine adherence or deviation from target architecture/application; also, work with project execution team to estimate the level of effort and project budget for the demand. 

Ensure that the team of Lab Systems Architects are aiding the Business Owner/requester by shaping the demands details to ensure alignment with the business objectives.  

Act as representative through the application approval process when addition of new application is being proposed  

E. Program Management & Stakeholder Engagement 

Lead and support smart/digital laboratory initiatives across manufacturing laboratories, service laboratories, and Quality Control laboratory, including requirements gathering, architecture definition, solution selection, and project execution. 

Collaborate with stakeholders including QA, Regulatory, Lab Operations, and Business Owners to ensure solutions meet compliance requirements and business expectations. 

Translate complex technical concepts into clear, actionable plans for both technical and non-technical audiences, including regulatory inspectors when required. 

Provide oversight or direct management of projects to ensure delivery on time, within budget, and in accordance with validation and quality standards. 

Minimum Qualifications 

Educational Background 

• Bachelors Degree in Computer Science, Engineering (mechanical, electrical, chemical, or industrial), Chemistry, Biology, or related scientific discipline. 

Work Experience 

At least 10 years of experience designing and implementing digital laboratory solutions in the pharmaceutical, biotechnology, or life sciences industry. 

Deep understanding of laboratory workflows, GxP regulations (CFR Part 11, Part 58), and validated system requirements. 

Proven track record with laboratory instrument integration into systems like LIMS, ELN, and LES. 

Strong experience working with digitalization and data flows from lab equipment to enterprise systems such as LIMS, LES, ERP, etc. 

Working understanding of the overall IT/OT technologies and processes for the Digital Plant Infrastructure (DPI) program, from level 0 to level 4. 

Familiarity with laboratory techniques, data analytics, and machine learning/AI concepts.

Preferred Qualifications 

Masters Degree in Computer Science, Engineering (mechanical, electrical, chemical, or industrial), Chemistry, Biology, or related scientific discipline

Working knowledge of regulatory guidelines from FDA, EMA, and ICH related to electronic records and lab systems validation. 

Experience supporting digital transformation efforts such as paperless labs, connected lab environments, or laboratory automation. 

Strong leadership, stakeholder engagement, and cross-functional collaboration skills. 

Experience with AI/ML initiatives, Analytical Information Markup Language (AnIML) and Allotrope Data Format (ADF), and scientific data analytics used by laboratory scientist and staff. 

Project management experience or certification (e.g., PMP, Agile) is a plus. 

Fluency in English, both written and spoken. 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!