Research Operations Manager

UNC-Chapel Hill•Chapel Hill, NC

2d•Onsite

About The Position

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 to 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.

Requirements

Knowledge and experience working in a cGMP Manufacturing Facility.
Two years of previous manufacturing experience.
Leadership experience and/or training in how to manage employees.
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.
Understanding of cell culture/ manufacturing techniques and their application in a cGMP Manufacturing Facility.

Nice To Haves

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

Responsibilities

Oversight and scheduling of CAR T batches, 3rd party drug products, and other manufactured products.
Coordinate activities with hospital coordinators and other program managers to ensure appropriate delivery of products.
Oversee and review executed activities to ensure work is completed in accordance with Standard Operating Procedures and Good Manufacturing Practices.
Communicate with PIs about the status of product manufacturing, acquire feedback, and collaborate on paths forward for patient product lines.
Manage manufacturing employees to ensure all work is completed and supported.
Ensure all employees are current on training requirements and have the necessary knowledge to execute their tasks.
Develop employees and the team to create a fully functional operation.
Serve in a leadership role regarding following and executing cGMP processes for all employees at the ACT Facility.
Ensure products meet all required quality standards.
Review and release drug product for distribution.
Assist in the implementation and deployment of initiatives for the ACT facility.
Coordinate activities/projects with Facility and Operations Directors input to ensure projects align with facility goals.
Make decisions on the execution of manufacturing processes.
Respond to facility issues quickly to have them resolved to not impact products for a patient.