Job DescriptionReporting to the Executive Director, Wilmington Laboratory Operations, the Director of Laboratory Instrumentation, Digital Systems & Connectivity is the senior technical leader accountable for the end-to-end design, start-up, and sustained operation of all laboratory instrumentation, digital laboratory systems, and enterprise connectivity platforms for the Wilmington Quality Control Laboratories.
This role will be a critical leader in the new facility and laboratory start-up program - supporting laboratory design, ensuring all necessary instrumentation and digital functionalities are incorporated, and leading start-up to meet all deliverables according to schedule. The role will define and execute the strategic vision for a fully connected, digitally enabled, paperless laboratory environment, ensuring that instrumentation, chromatography data systems (CDS), laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), and enterprise data platforms are seamlessly integrated to enable the end-to-end analytical lifecycle. This includes driving the adoption of advanced digital tools, automation, and data analytics to support a new paradigm for analytical commercialization of high potent Biologics. Post laboratory start-up, the role will provide ongoing strategic leadership for instrumentation lifecycle management, digital system optimization, and continuous improvement of laboratory connectivity and data integrity across the site.
Key Accountabilities:New Facility & Laboratory Start-Up: - Support the design of the laboratory facility, partnering with Engineering, Quality, Digital, Manufacturing, and IT to ensure all necessary instrumentation, digital infrastructure, and connectivity functionalities are incorporated to support the end-to-end analytical lifecycle.
- Lead the design and specification of laboratory infrastructure requirements as they relate to instrumentation and digital systems; partner with Engineering and IT teams to ensure fit-out and utility provisions meet requirements.
- Develop and execute the integrated start-up master plan for instrumentation, digital systems, and laboratory connectivity, ensuring all deliverables are met according to schedule.
- Define and execute the commissioning, qualification, and validation (CQV) strategy for all laboratory instrumentation and digital systems, including IQ/OQ/PQ protocols and validation master plans; develop the phased equipment delivery, installation, and qualification schedule aligned with facility construction milestones.
- Support the execution of the laboratory operational readiness plan ensuring all systems are validated and inspection-ready prior to Health Authority submissions, including pre-approval inspection (PAI) readiness.
- Support the development of EHS policies and practices for the laboratory as they relate to instrumentation and high potent compound containment.
Instrumentation Lifecycle Management - Accountable for QC instrumentation strategy, selection, procurement, and delivery planning across all analytical platforms (HPLC/UPLC, mass spectrometry, spectroscopy, bioanalytical instruments, etc.) in partnership with global groups (Quality, IT, Digital, Analytical R&D, etc.)
- Lead instrument commissioning, qualification (IQ/OQ/PQ), and validation programs ensuring right-first-time execution and regulatory compliance.
- Develop and implement risk-based maintenance, calibration, and requalification strategies; manage vendor and qualification service provider relationships to ensure ongoing instrumentation is maintained in a fully validated and calibrated state, on schedule, on budget, and inspection-ready
Quality & Compliance: - Accountable for instrumentation related activities including review and approval of SOPs, protocols, and qualification documentation
- Serve as the subject matter expert during health authority inspections for instrumentation and laboratory systems.
- Lead investigations for system-related deviations, OOS/OOT events, and data integrity incidents; drive root cause analysis and CAPAs.
Strategic & Technical Leadership - Provide strategic direction and technical leadership for all laboratory instrumentation, digital systems, and connectivity platforms, ensuring alignment with site, network, and enterprise quality and digital objectives.
- Partner with cross-functional stakeholders (IT, Quality, Engineering, Manufacturing, Regulatory, Digital) to align laboratory digital strategy with global quality, compliance, and digital transformation priorities.
- Own the architecture and integration strategy for the connected laboratory ecosystem including LIMS, CDS (i.e. Empower), ELN, and enterprise data lakes
- Deploy advanced analytics, dashboards, and real-time monitoring tools for proactive instrument performance management and predictive maintenance.
- Champion automation, AI, and digital technologies to optimize laboratory throughput and data quality
Qualifications / experience Education - Bachelor's degree in Analytical Chemistry, Biology/Biochemistry, Engineering, Computer Science, or related discipline. Advanced degree preferred.
Experience - 12+ years of progressive industry experience in pharmaceutical/biotech laboratory operations with direct expertise in laboratory instrumentation, digital systems, and/or laboratory IT in a GxP environment.
- Demonstrated experience with new facility/laboratory start-up, such as facility design input, CQV strategy and execution, start-up master planning, and Health Authority approval readiness (PAI preparation).
- Expertise in LIMS, CDS (e.g., Empower), ELN, and instrument data management platforms.
- Proven experience designing and/or implementing connected/paperless laboratory environments.
- Strong understanding of data integrity requirements (ALCOA+, 21 CFR Part 11, EU Annex 11).
- Strong Quality background with direct experience defending content during health authority inspections preferred.
- Proven leadership including cross-functional stakeholder engagement
- 5+ years leading a team in a regulated Quality laboratory environment.
Core competencies and skills - Technical leadership in laboratory instrumentation and digital systems architecture
- Deep expertise in laboratory IT, data integrity, and enterprise connectivity in GxP environments
- Experience in data analysis, trending, and/or other types of digital media in the pharmaceutical/biotech industries strongly preferred
- Proven track record in new laboratory/facility start-up from design through operational readiness
- Experience implementing automation, advanced analytics, and/or AI in laboratory operations
- Strong regulatory knowledge for computerized systems and instrument qualification
- Effective cross-functional leadership and stakeholder influencing in greenfield environments
- Knowledge of EHS requirements for high potent compound containment preferred
Additional Info: - Location: Wilmington Delaware (On-Site)
- Travel: Ability to travel ~10% of the time
Required Skills: Analytical Chemistry, Analytical Instrumentation, Antibody Drug Conjugates (ADC), Digital Diagnostic Equipment, Innovation, Laboratory Design, Laboratory Information Management System (LIMS), Laboratory Instrumentation, Mass Spectrometry (MS), Program Startup, Qualitative Testing, Quality Improvement Programs, Quantitative Assay, Spectrometry, Strategy Execution, Team Coordination, Technical Leadership
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status: Regular
Relocation:Domestic
VISA Sponsorship:No
Travel Requirements:10%
Flexible Work Arrangements:Not Applicable
Shift:1st - Day
Valid Driving License:No
Hazardous Material(s):n/a
Job Posting End Date:07/28/2026
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