Manager, Bioanalytical Systems & Digital Enablement

Strategy, Governance, and Execution

• Co-develop the global roadmap for bioanalytical systems and digital platforms with input from site stakeholders and functional partners
• Establish governance that incorporate local requirements and stakeholder input while promoting standardization, scalability, and compliance across all sites
• Act as both program lead and execution resource, facilitating alignment and consensus across stakeholders.
• Lead global implementations, upgrades, and migrations with active personal involvement where required and in collaboration with site teams
• Interface with Celerion support teams and site representatives on implementation and utilization of business systems
• Support development and coordination of AI initiatives in partnership with operations and site stakeholders

Hands-On System Administration & Support

• Directly administer and maintain laboratory systems (LIMS, ELN, CDS, and related platforms) as needed, in alignment with site requirements and governance processes
• Manage user access, roles, and permissions in compliance with data integrity requirements and site leadership
• Monitor system performance, troubleshoot issues, and resolve support tickets, coordinating with local users and support teams
• Support and/or perform system configuration, upgrades, patching, and integrations, ensuring stakeholder awareness and input where relevant
• Oversee and contribute to instrument integration and data flow between lab systems, working closely with site teams
• Maintain system documentation and support audit and inspection readiness

Integration & Data Flow

• Ensure end-to-end data flow and visibility across the bioanalytical lifecycle in collaboration with system owners and site stakeholders
• Drive integration across systems and platforms, balancing global standards with local operational needs
• Identify and implement opportunities for automation and efficiency gains in partnership with users and functional teams

Collaboration & Cross-Site Alignment

• Facilitate strong alignment between US and Switzerland laboratories through active stakeholder engagement and shared decision-making
• Act as a key connector between IT, Bioanalytical Operations, QA, and other departments
• Drive global consistency while incorporating local input and constraints
• Facilitate communication, prioritization, and execution across regions and functions, ensuring transparency in decision processes

Innovation & Continuous Improvement

• Promote adoption of AI, automation, and advanced analytics in collaboration with stakeholders and subject matter experts
• Evaluate new technologies and manage vendor relationships incorporating cross-functional and site feedback into recommendations
• Drive continuous improvement in system utilization, throughput, and data quality through joint initiatives with operational teams

Compliance & Quality

• Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements in partnership with QA and system stakeholders
• Support CSV activities and inspection readiness, working closely with QA and site representatives
• Support audits and provide system documentation and evidence with input from relevant stakeholders

Adoption & Support Model

• Drive user adoption through training and change management, in collaboration with site leadership and users
• Define and implement support models with input from global and local stakeholders
• Provide leadership and serve as a technical escalation point, while coordinating with relevant teams for resolution and decision-making