UTS - Temporary Project Manager at UNC Chapel Hill

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Department: 480502 - UHR UTS/UNC Partnership

Location: Chapel Hill, NC

Essential Job Duties:

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.

Other Work/Responsibilities:

Description |

Function | Research- Development |

70% | Collaborate with IGI directors to discuss, develop, review, and implement policies, protocols, and operations for mRNA/ LNP manufacturing.Assist with strategic planning of program operationsOversee the personalized neoantigen vaccine manufacturing process, including drafting SOPs, technical transfer documents, change control, validation workLead and participate in program meetings and ad hoc project-specific meetings as required. |

Function | Research- Project Management |

25% | Oversee all activities that need to occur that will bring the manufacturing process from outside contractor services into the GMP facilityUse, update, and train staff in project management dashboards and LIMS systemsGenerate project milestones, timelines, budgets, and reporting.Maintain detailed records in an electronic lab notebook. |

Function | Other Duties |

5% |

Other duties as needed.

Required Qualifications:

• 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.

Preferred Qualifications:

• Industry experience leading a mRNA/ LNP manufacturing team in vaccine manufacturing applications, ideally in manufacturing personalized neoantigen vaccines for cancer.

Required license or certification:

n/a

Position Number: 48KB36

AA/EEO Statement:

NC State University is an equal opportunity employer. All qualified applicants will receive equal opportunities for employment without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex (including pregnancy), sexual orientation, and veteran status. The University encourages all qualified applicants, including protected veterans and individuals with disabilities, to apply. Individuals with disabilities requiring disability-related accommodations in the application and interview process are welcome to contact 919-513-0574 to speak with a representative of the Office of Equal Opportunity.

If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or [email protected].

Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.

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