GMP Research Operations Manager

University of North Carolina at Chapel Hill; Chapel Hill (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

UNC’s Advanced Cellular Therapeutics Facility is seeking a Research Operations Manager to oversee the 31,542 sq ft GMP manufacturing space, maintain environmental controls, and coordinate building services to prevent any manufacturing disruption while producing human cellular therapy products for patients receiving adoptive cell therapy.

You will lead a team of four, work with vendors, manage equipment lifecycle and calibration, enforce qualification activities (IQ/OQ/PQ), and partner with

Qualifications

• Bachelor’s degree required; two years of general research experience or equivalent.
• Knowledge of GMP and its application in manufacturing environments.
• Experience with metrology, calibration and preventive maintenance of equipment.
• Familiarity with HVAC systems in GMP cleanrooms.
• Understanding of Installation, Operation, and Process Qualification (IQ/OQ/PQ) activities.

Responsibilities

• Oversee the 31,542 sq ft GMP manufacturing facility and ensure continuous operation with proper environmental controls.
• Coordinate building maintenance, repairs and vendor activities to avoid disruptions to production.
• Lead and mentor a team of four staff; manage equipment lifecycle, calibration, and maintenance planning.
• Collaborate with manufacturing, quality, and facilities to enforce room requirements and process qualification activities (IQ/OQ/PQ).
• Support space planning, vendor interactions, and purchasing processes for facility projects.

Skills

MS Office

GMP knowledge

Metrology & calibration

HVAC knowledge

IQ/OQ/PQ processes

Education

Bachelor’s degree in a related field

Tools

Microsoft Office

Job description

UNC’s Advanced Cellular Therapeutics Facility is seeking a Research Operations Manager to oversee the 31,542 sq ft GMP manufacturing space, maintain environmental controls, and coordinate building services to prevent any manufacturing disruption while producing human cellular therapy products for patients receiving adoptive cell therapy.

You will lead a team of four, work with vendors, manage equipment lifecycle and calibration, enforce qualification activities (IQ/OQ/PQ), and partner with