professional opportunities that span the campus and community.University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package , paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.
Primary Purpose of Organizational Unit:
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research.
Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.
Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.
Position Summary:
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.
Minimum Education and Experience Requirements:
Bachelor’s degree and two years of general research experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience:
- 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.
Preferred Qualifications, Competencies, and Experience:
- 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.
Campus Security Authority Responsibilities:
Not Applicable.
