Manager, Bioanalytical Systems & Digital Enablement

Celerion; Fehraltorf; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Celerion, a leader in bioanalytical contract research, invites a Manager for Bioanalytical Systems & Digital Enablement at the Fehraltorf/Zurich site. You will coordinate global system strategy, governances, and administration of LIMS, ELN, and CDS while partnering with IT, QA, and operations.

You will lead global implementations, drive automation, and ensure data integrity and GxP compliance across sites, balancing strategic aims with hands-on execution.

Qualifikationen

• 8–12+ years of experience in bioanalytical, clinical research, or regulated environments.
• Hands-on experience with laboratory systems (LIMS, ELN, CDS).
• Strong knowledge of GxP, data integrity, and CSV.
• Proven ability to lead strategic initiatives and work across global teams.

Aufgaben

• Co-develop the global roadmap for bioanalytical systems and digital platforms with input from site stakeholders and partners.
• Lead global implementations, upgrades, and migrations with active involvement and site collaboration.
• Administer and maintain laboratory systems (LIMS, ELN, CDS); manage access and configurations.
• Ensure GxP compliance, data integrity, and CSV readiness in partnership with QA.
• Drive adoption of AI, automation, and advanced analytics in lab operations.
• Coordinate alignment between US and Switzerland laboratories and cross-site teams.

Kenntnisse

LIMS

ELN

CDS

System administration

GxP compliance

Data integrity

Cross-functional collaboration

Stakeholder management

Data integration

Ausbildung

Bachelor’s degree in IT/Life Sciences

Tools

LIMS

ELN

CDS

CSV

Jobbeschreibung

For over 40 years, Celerion has stood the forefront of global bioanalytical contract research, partnering with pharmaceutical and biotech innovators to bring new therapies to patients faster. Our growing Fehraltorf/Zurich site it at the hear of that mission.

THE OPPORTUNITY

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

This role combinesstrategiccoordinationwithhands‑onoperational execution, ensuring thatgloballaboratory systems (e.g., LIMS, ELN, instrument integration) and operational tools are effectively implemented,utilized, compliant, and continuously optimized.

Operating at the intersection ofscience, 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
• FacilitatesalignmentbetweenUS and Switzerland laboratoriesthrough partnership and shared decision‑making
• Works closely withIT, Operations, QA,site teamsand other functionsto deliver integratedand practicalsolutions

Strategy, Governance, and Execution

• Co‑develop theglobal roadmapfor bioanalytical systems and digital platformswith input from site stakeholders and functional partners
• Establish governancethatincorporate local requirements and stakeholder inputwhile promotingstandardization, scalability, and complianceacross all sites
• Act as bothprogram lead and execution resource,facilitating alignment and consensus across stakeholders.
• Lead global implementations, upgrades, and migrations withactive personal involvement where requiredand in collaboration with site teams

Hands‑On System Administration & Support

• Directlyadminister and maintain laboratory systems(LIMS, ELN, CDS, and related platforms) as needed,in alignment with site requirements and governance processes
• Manageuser access, roles, and permissionsin compliance with data integrity requirementsand site leadership
• Monitor system performance, troubleshoot issues, andresolve support tickets,coordinating with local users and support teams
• Support and/or performsystem configuration, upgrades, patching, and integrations, ensuring stakeholder awareness and input where relevant
• Oversee and contribute toinstrument integration and data flowbetween lab systems,working closely with site teams
• Maintain system documentation and supportaudit and inspection readiness

Integration & Data Flow

• Ensureend‑to‑end data flow and visibilityacross the bioanalytical lifecyclein collaboration with system owners and site stakeholders
• Drive integration across systems and platforms,balancing global standards with local operational needs
• Identify and implement opportunities forautomation and efficiency gainsin 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 betweenIT, Bioanalytical Operations, QA,and other departments
• Driveglobal consistency whileincorporating local input and constraints
• Facilitate communication, prioritization, and execution across regions and functions,ensuring transparency in decision processes

Innovation & Continuous Improvement

• Promoteadoption ofAI, automation, and advanced analyticsin collaboration with stakeholders and subject matter experts
• Evaluate new technologies and manage vendor relationshipsincorporating cross‑functional and site feedback into recommendations
• Drive continuous improvement insystem utilization, throughput, and data qualitythrough joint initiatives with operational teams

Compliance & Quality

• Ensure compliance withGxP, 21 CFR Part 11, and data integrity requirementsin partnership with QA and system stakeholders
• Support CSV activities and inspection readiness, working closelywith QAand site representatives
• Support audits and provide system documentation and evidencewith input from relevant stakeholders

Adoption & Support Model

• Driveuser adoptionthrough trainingandchange management, in collaboration with site leadership and users
• Define and implementsupport modelswith input from global and local stakeholders
• Provide leadershipand serve as a technical escalation point, while coordinating with relevant teams for resolution and decision‑making

• 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 leadingsystem implementations and digital transformation initiatives
• Deep understanding ofGxP compliance, data integrity, and validated systems (CSV)
• Proven ability to operate in both:
• Strategic leadership capacity
• Hands‑on technical execution role
• Experience working acrossglobal teams (US and Europe preferred)
• Knowledge ofdata integration, automation, and AI/ML applicationsin lab environments
• Strong stakeholder management and cross‑functional collaboration skills