UTS - Temporary Quality Assurance mRNA/ LNP Project Lead at UNC Chapel Hill

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Department: 480502 - UHR UTS/UNC Partnership

Location: Chapel Hill, NC

Essential Job Duties:

The Quality Assurance Specialist drives the successful technical transfer and cGMP manufacturing of advanced mRNA and Lipid Nanoparticle ( LNP ) therapies. Operating directly on the cleanroom floor, this role provides real-time quality oversight, authors critical process documentation, leads deviation investigations, and ensures strict regulatory compliance to safely advance cutting-edge biopharmaceutical products from transfer through production.

Other Work/Responsibilities:

• Support the technical transfer of mRNA and LNP manufacturing to the UNC Lineberger ACT Facility.

Provide Quality direction to project manager and manufacturing personnel.

Execute activities such as change controls, validations, SOP creation for implementing the new manufacturing process.

• Batch Review

Completes initial review of batch records in real time and provides feedback on manufacturing operations.

Coordinates with QC -Equipment and QC – EM Roles on manufacturing needs.

• On the floor Quality support in clean room manufacturing reviewing completed activities.

• Initiates and investigates Occurrences that occur during manufacturing.

• Responsible for tracking manufacturing errors and providing feedback for metrics.

• Technical Writer and resource for policies, Standard Operating Procedures, forms, worksheets, and job aids in support of quality and manufacturing operations.

Assists and supports manufacturing in identifying needed policies, Standard Operating Procedures, and other required documents.

• Ensures manufacturing employees are current on required training for them to complete operations.

• Looks to implement and reinforce best practices used in manufacturing operations in conjunction with production staff.

• Helps to be liaison for manufacturing to support projects.

• Maintain annual competencies in required quality functions and remain up to date in required EHS LMS modules.

• Assist in training other QA/QC members on mRNA/ LNP activities so they may support.

• Assist in the maintenance of quality electronic systems.

• Participate in 5 hours of continuing education annually in cellular therapy or quality topics.

Responsibilities may be modified or added as needed and discussed with the Assistant Director of QA/QC and/or Associate Director of Quality and Facility Director.

Required Qualifications:

• Extensive experience in cGMP mRNA/ LNP manufacturing, including expertise in the relevant regulatory and scientific aspects of manufacturing workflows.

• Quality Assurance experience

• Excellence in planning and execution

• Excellent skills in verbal and written communication.

Preferred Qualifications:

• Experience with mRNA/ LNP manufacturing is required.

Required license or certification:

n/a

Position Number: 48CK44

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.

NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.