Director, Bioanalytical Services

About the role

Director, Bioanalytical Technical Operations provides strategic and operational leadership for the computerized systems, digital workflows, and technical processes that support regulated bioanalytical laboratory services. The role serves as the business owner and senior operational authority for electronic laboratory notebook and laboratory information management platforms, including IDBS E-Workbook/ELN and Thermo Scientific Watson LIMS (or similar), ensuring that systems are fit for purpose, validated, compliant, reliable, and aligned with laboratory and client needs.

Responsibilities

• Own the bioanalytical technical operations strategy and roadmap for laboratory digital systems, with primary oversight of IDBS E-Workbook/ELN, inventory and laboratory execution workflows, and Watson LIMS.
• Serve as Business System Owner or senior business representative for assigned applications, providing lifecycle direction and approving business-process, configuration, access, and use decisions.
• Ensure systems support the end-to-end bioanalytical workflow, including study setup, sample receipt and chain of custody, inventory and materials control, run preparation and execution, data processing, quality control review, reporting, study closeout, and archiving.
• Establish governance, operating standards, performance measures, and escalation pathways for computerized laboratory systems across bioanalytical sites.
• Partner with laboratory operations, scientific leadership, Quality and Compliance, Information Technology, validation, data management, and vendors to translate business needs into scalable and harmonized solutions.
• Direct system implementations, upgrades, integrations, enhancements, testing, deployment, and adoption while managing scope, resources, risks, dependencies, timelines, and business continuity.
• Ensure validated systems and electronic records comply with applicable GxP requirements, data-integrity principles, 21 CFR Part 11, EU Annex 11, internal policies, and client commitments.
• Oversee role-based access, periodic access reviews, electronic signatures, audit-trail controls and review processes, change control, incident and problem management, periodic review, disaster recovery, and system retirement.
• Ensure IDBS workflows provide complete and traceable documentation of experiments, materials, reagents, equipment, inventory, and approvals, including expiry and calibration controls.
• Ensure Watson LIMS supports accurate sample management, study and assay configuration, data processing, sample reconciliation, reporting, and complete chain-of-custody records.
• Lead process mapping and continuous-improvement initiatives that reduce manual effort, standardize laboratory execution, strengthen right-first-time performance, and advance paperless operations and electronic archiving.
• Monitor service levels, system availability, data quality, user adoption, deviations, recurring issues, and improvement benefits; report performance and risks to senior leadership.
• Provide inspection and client-audit readiness for computerized systems and represent Bioanalytical Technical Operations during sponsor audits, regulatory inspections, and governance reviews.
• Provide leadership, coaching, prioritization, and resource planning for technical operations personnel, system administrators, subject-matter experts, and project teams.
• Manage vendor relationships, licenses, support models, budgets, contracts, and technology investments for assigned bioanalytical platforms.
• Maintain awareness of emerging laboratory informatics, automation, and data-management capabilities and develop business cases for adoption where they improve quality, compliance, capacity, or client delivery.

Qualifications

• Bachelor’s degree in a scientific, engineering, information-systems, or related discipline; advanced degree preferred.
• Extensive experience in regulated bioanalytical laboratory operations, laboratory informatics, computerized-system governance, or a related pharmaceutical or contract research environment.
• Demonstrated leadership experience with electronic laboratory notebook, laboratory execution, or LIMS platforms; direct experience with IDBS E-Workbook/ELN and Watson LIMS strongly preferred.
• Strong working knowledge of computerized-system validation, data integrity, audit trails, electronic records and signatures, access governance, change control, incident management, and inspection readiness.
• Proven ability to lead complex, cross