Research Operations Manager

UNC-Chapel Hill•Chapel Hill, NC

4d•Onsite

About The Position

UNC’s Advanced Cellular Therapeutics Facility is looking for a qualified Research Operations Manager to join their team to support the work of developing and producing human cellular therapy products for patients receiving adoptive cell therapy for the treatment of cancer. The Advanced Cellular Therapeutics Facility manufactures human cellular therapy products under Good Manufacturing Practices (GMP) that is regulated by the U.S. Food and Drug Administration (FDA). The Research Operations Manager role supports the operation of the 31,542 sq ft, two-floor manufacturing facility that includes 14 ISO 7 cleanrooms totaling roughly 17,500 sq ft. This role maintains continuous oversight of temperature, humidity, and room pressures to ensure all spaces remain within ISO 7 GMP specifications, providing 24/7 monitoring and rapid response to any environmental excursions that could jeopardize room accessibility, product integrity, or human patient treatments. This role serves as a key liaison with UNC Real Estate and Development Facilities to coordinate building maintenance, repairs, and construction activities, ensuring work is scheduled without disrupting manufacturing operations. The Research Operations Manager must be knowledgeable in HVAC and building systems to guide third-party service providers, operate the Building Electronic Management System, and communicate alarms or troubleshooting needs. They work closely with manufacturing and quality teams to enforce room requirements, document impacts, and segregate affected areas when necessary. The role also includes investigating and resolving building issues with vendors, managing capital projects related to facility systems and equipment, tracking equipment lifecycles, planning replacements, and evaluating new equipment purchases. Additionally, the Facility Manager trains and mentors other team members, building internal capability for equipment maintenance and calibration to reduce reliance on external providers. They will be responsible for the equipment lifecycle from onboarding, calibration, preventative maintenance, and decommissioning. The Research Operations Manager role requires a person who understands Installation, Operational, and Process Qualification activities that must occur during the implementation of equipment used onsite, how those activities can impact the manufacturing process, and all related safety compliance measures. The role will be required to interact with vendors on a daily basis scheduling activities, reviewing technical reports for acceptance, managing supply logistics, and ensuring equipment is maintained on a schedule to complete all calibrations and preventative maintenance. This role is responsible for responding to equipment issues and facility problems, investigating root causes, developing a corrective action plan, having it approved, and putting it into place, while also supporting space planning to ensure operational continuity. This role needs to understand purchasing systems at the university as they will submit for purchase orders and quotes to have work performed at the facility. They will oversee any building work and ensure work is completed per quotes. The person must be able to work independently with little oversight and multi-task a number of ongoing activities. Additionally, the role must respond to equipment/facility issues quickly to have them resolved so as to not impact products for a patient. This role will oversee 4 staff members as they execute qualification activities, manage equipment, and support external vendors. This role will plan and schedule their work accordingly as well as develop and educate them.

Requirements

Knowledge of Microsoft Office software (Word, Excel, Power Point)
Knowledge of Good Manufacturing Practices and how they are utilized in a manufacturing environment.
Knowledge of metrology, calibration and preventative maintenance of equipment
Knowledge of HVAC systems for GMP cleanrooms
Knowledge around the Installation, Operation, and Process Qualification process for equipment and systems.

Nice To Haves

Five years’ experience working and supporting a GMP manufacturing facility as a Metrology or HVAC Technician.
Five years of leadership experience working and developing other employees.

Responsibilities

Maintain continuous oversight of temperature, humidity, and room pressures to ensure all spaces remain within ISO 7 GMP specifications.
Provide 24/7 monitoring and rapid response to any environmental excursions.
Serve as a key liaison with UNC Real Estate and Development Facilities to coordinate building maintenance, repairs, and construction activities.
Guide third-party service providers on HVAC and building systems.
Operate the Building Electronic Management System.
Communicate alarms or troubleshooting needs.
Enforce room requirements, document impacts, and segregate affected areas when necessary.
Investigate and resolve building issues with vendors.
Manage capital projects related to facility systems and equipment.
Track equipment lifecycles, plan replacements, and evaluate new equipment purchases.
Train and mentor other team members, building internal capability for equipment maintenance and calibration.
Manage the equipment lifecycle from onboarding, calibration, preventative maintenance, and decommissioning.
Understand Installation, Operational, and Process Qualification activities.
Interact with vendors on a daily basis scheduling activities, reviewing technical reports for acceptance, managing supply logistics, and ensuring equipment is maintained on a schedule.
Respond to equipment issues and facility problems, investigate root causes, develop a corrective action plan, have it approved, and put it into place.
Support space planning to ensure operational continuity.
Submit for purchase orders and quotes for facility work.
Oversee any building work and ensure work is completed per quotes.
Respond to equipment/facility issues quickly to have them resolved so as to not impact products for a patient.
Plan and schedule the work of 4 staff members.
Develop and educate staff members.