Laboratory Manager

Laboratory Manager

Our combination-device client seeks a hands-on Laboratory Manager to oversee laboratory operations, staff, equipment readiness, and drug-device combination-product testing. Partner with Engineering, Quality, and Operations to maintain compliance, improve capacity and throughput, and meet client commitments.

Responsibilities

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• Manage daily priorities, staffing, training, sample flow, testing readiness, documentation, and delivery risks.
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• Lead test method development, optimization, validation/verification, troubleshooting, and failure investigations for autoinjectors, pen injectors, prefilled syringes, and on-body injectors.
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• Oversee functional and dimensional testing, including force/torque, dose accuracy, delivered volume, injection/delivery time, needle performance, adhesion, leakage, alarms, and fault handling.
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• Direct fixture development, equipment selection, and repeatability/reproducibility studies.
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• Own equipment qualification, calibration, maintenance, repairs, and documentation; maintain materials and inventory controls, including receiving, storage, traceability, expiration, and disposition.
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• Partner with Quality on protocols, reports, deviations, nonconformances, CAPAs, change controls, and audit readiness.
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Required Qualifications

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• Bachelor’s in Engineering, Chemistry, Biology, Materials Science, or a related technical field; equivalent relevant experience may be considered.
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• 5+ years of laboratory, engineering, manufacturing, or technical operations experience in a regulated or quality-driven environment, including 2+ years of people leadership.
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• Direct experience with test methods, protocols, validation/verification, troubleshooting, and testing requirements for autoinjectors, pen injectors, prefilled syringes, and on-body injectors.
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• Working knowledge of cGMP, ISO 13485, ISO 17025, or comparable requirements and documentation practices.
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• Experience with laboratory operations, equipment qualification, calibration, maintenance, and quality investigations, CAPAs, audits, or out-of-tolerance events.
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Preferred Qualifications

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• Consulting, contract-development, testing, or service-based organization experience.
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• Materials management, inventory, receiving, traceability, stockroom, or warehouse experience.
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• Knowledge of ISO 11608, ISO 11040, ISO 14971, IEC 62366, and relevant USP chapters.
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• Experience with fixtures, equipment selection, repeatability/reproducibility studies, Lean, 5S, or visual management.
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• Proficiency with Excel and inventory, maintenance, ERP, QMS, or scheduling systems.
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Term & Start

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• Permanent position
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• Full-time, 40 hours/week
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• Onsite in Illinois 4+ days/week
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• Immediate start
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