Research Operations Manager

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and 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.

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.

UNC's Advanced Cellular Therapeutics Facility is looking for a qualified Research Operations Manager to join their team to help organize and ensure manufacturing operations are maintained. This includes that the employee will support the production of cellular therapy and other manufactured drugs under Good Manufacturing Practices regulatory guidelines for patients receiving a multitude of therapies for the treatment of cancer and other diseases. This role will be responsible for the oversight and scheduling of CAR T batches, 3rd party drug products, and other manufactured products as required. This role will coordinate activities with the hospital coordinators and other program managers the ensure appropriate delivery of products. This role will oversee and provide review of executed activities to ensure work is being completed in accordance with Standard Operating Procedures and Good Manufacturing Practices. Employee will communicate with PIs about status of product manufacturing, acquire feedback, and collaborate on paths forward for patient product lines.

This role will manage manufacturing employees to ensure all work is completed and supported. Will ensure all employees are current on training requirements and has the knowledge necessary to execute their tasks. Develop employees and the team to create a fully functional operation that is not dependent upon any one employee for any single activity.

This role requires a person who understands cell culture/ manufacturing techniques and their application in a cGMP Manufacturing Facility. This involves serving in leadership role regarding following and executing cGMP processes for all employees at the ACT Facility. Person will work to ensure that the products meet all required quality standards and will be expected to review and release drug product for distribution.

The person will assist in the implementation and deployment of initiatives for the ACT facility. The employee is expected to interact and coordinate activities/ projects with Facility and Operations Directors input to ensure projects align with facility goals. The employee work independently with little oversight and multi-task a number of ongoing activities. The person will be expected to make decisions on the execution of manufacturing processes. Additionally, the role must respond to facility issues quickly to have them resolved to not impact products for a patient.

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.

Requires knowledge and experience working in a cGMP Manufacturing Facility. Two years of previous manufacturing experience is necessary. Has leadership experience and or training in how to manage employees. Has excellent Word and Excel skills. Ability to write and execute deviation investigations, CAPA, and revise SOPs. Ability to analyze data and information and report to management. Ability to work with others to help them understand manufacturing techniques used in process.

Prior experience working with transducing retrovirus for manufacturing human cellular therapy products is highly desired. Understanding cell culture processes and how Quality Systems are applied to them.

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.