Laboratory Operations Manager

GForce Life Sciences; Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Job summary

GForce Life Sciences is seeking a hands-on Laboratory Manager to oversee operations, staff, and equipment for drug-device combination-product testing. You will partner with Engineering, Quality and Operations to improve capacity, throughput, and client commitments.

You will manage daily priorities, lead method development and testing for autoinjectors and related devices, ensure cGMP/ISO documentation, and drive equipment Qualification and CAPA processes in a regulated setting.

Qualifications

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

Responsibilities

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

Skills

People leadership

Documentation

Education

Bachelor’s degree in a technical field

Tools

Excel

ERP systems

QMS

Job description

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

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

Required Qualifications

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

Preferred Qualifications

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