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Position Summary
Our new Initiative for Generative Immunotherapy (IGI), a collaborative and multidisciplinary translational tumor immunology group tasked with preclinical research and clinical trials in personalized antigen-directed immunotherapy, is seeking to hire a Manufacturing Project Manager who will be tasked with supporting the technical transfer of manufacturing operations for mRNA/LNP activities to the UNC Lineberger ACT Facility. This will also consist of performing manufacturing of personalized neoantigen vaccines using mRNA/LNP formulations. The successful applicant will have deep expertise in workflows for clinical GMP mRNA/LNP production, including facility with physical science and regulatory aspects of manufacturing. They should be able to work within a collaborative team of IGI personnel and external consultants to develop new manufacturing capacity in UNC GMP facility space, train personnel, and supervise mRNA/LNP manufacturing as part of personalized neoantigen vaccine clinical trials. They will lead a multidisciplinary team to manufacture clinical vaccine products as well design and conduct experiments to test potential improvements to the mRNA/LNP vaccine manufacturing process. They will be responsible for generating SOPs, process tracking, and training of experimental staff. There will be substantial interaction with lab members working on correlative studies and bioinformatics analyses along with involvement in IGI strategic direction-setting. If desired, the applicant will have the opportunity to be the lead author on presentations, manuscripts, and/or other products derived from their work. They will also be responsible for data reporting according to FDA regulations, sponsor requests, and assisting computational staff with data management and data sharing.
Minimum Education and Experience Requirements
Experience with mRNA/ LNP manufacturing is required.
- Extensive experience in cGMP mRNA/LNP manufacturing, including expertise in the relevant regulatory and scientific aspects of manufacturing workflows.
- Experience in Project Management
- Excellence in planning and execution
- Excellent skills in verbal and written communication.
Management Preferences
- Industry experience leading a mRNA/LNP manufacturing team in vaccine manufacturing applications, ideally in manufacturing personalized neoantigen vaccines for cancer.
Special Instructions
UNC-Chapel Hill and NC State University are collaborating to extend NC State’s internal temporary staffing function as a shared service for both institutions. Under this partnership, UTS provides exclusive temporary staffing services to UNC-Chapel Hill and NC State, employing candidates to work as temporary employees in a variety of jobs on both campuses. If interested, please apply here: https://jobs.ncsu.edu/postings/236947
