Manager, Bioanalytical Systems & Digital Enablement

Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.  

The Manager, Bioanalytical Systems & Digital Enablement is responsible for coordinating global strategy, governance, and administration of bioanalytical laboratory systems and supporting digital platforms in close partnership with stakeholders.

This role combines strategic coordination with hands-on operational execution, ensuring that global laboratory systems (e.g., LIMS, ELN, instrument integration) and operational tools are effectively implemented, utilized, compliant, and continuously optimized.

Operating at the intersection of science, operations, and IT, this role:

• Facilitates development and execution of a globally aligned system strategy in collaboration with local stakeholders
• Acts as a hands-on system owner and administrator, supporting day-to-day operations
• Facilitates alignment between US and Switzerland laboratories through partnership and shared decision-making
• Works closely with IT, Operations, QA, site teams and other functions to deliver integrated and practical solutions

The position serves as both a global coordinator and working leader, accountable for enabling system performance, supporting project delivery, and day-to-day operational support, while ensuring that key decisions are made collaboratively with relevant stakeholders.

Essential Functions

• Responsible for staff management in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees

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

Knowledge, Skills and Experience

• Bachelor’s degree in IT, Life Sciences, or related field (advanced degree preferred)
• 8–12+ years of experience in bioanalytical, clinical research, or regulated environments
• Strong hands-on experience with:
• Laboratory systems (LIMS, ELN, CDS)
• System administration, configuration, and troubleshooting
• Experience leading system implementations and digital transformation initiatives
• Deep understanding of GxP compliance, data integrity, and validated systems (CSV)
• Proven ability to operate in both:
• Strategic leadership capacity
• Hands-on technical execution role
• Experience working across global teams (US and Europe preferred)
• Knowledge of data integration, automation, and AI/ML applications in lab environments
• Strong stakeholder management and cross-functional collaboration skills

Celerion Values:       Integrity   Trust   Teamwork   Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.