Director, Bioanalytical Services
ICON
ICON seeks a Director of Bioanalytical Technical Operations to provide strategic leadership for computerized systems, digital workflows, and technical processes supporting regulated bioanalytical laboratory services. The role oversees electronic laboratory notebooks, laboratory information management platforms, and ensures systems remain validated, compliant, and aligned with laboratory and client needs.
Responsibilities
- Develop and own bioanalytical technical operations strategy and digital systems roadmap
- Serve as business system owner for LIMS and ELN platforms, approving business processes and configuration decisions
- Establish governance, operating standards, and performance measures for laboratory computerized systems
- Direct system implementations, upgrades, and deployments while managing scope, resources, and timelines
- Lead process mapping and continuous improvement initiatives to standardize execution and reduce manual effort
Requirements
- Bachelor's degree in science, engineering, information systems, or related field
- Extensive experience in regulated bioanalytical laboratory operations or informatics
- Experience with computerized system governance in pharmaceutical or contract research environments
- Advanced degree preferred
- Demonstrated expertise with laboratory information management systems and electronic laboratory notebooks
- Knowledge of GxP requirements, 21 CFR Part 11, and EU Annex 11 compliance
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