Principal Engineer, MS&T

Role: Principal Engineer, MS&T, focused on gene therapy manufacturing, providing scientific and technical leadership in upstream processes such as mammalian cell culture and gene therapy platforms. Responsibilities include leading process verification, troubleshooting complex manufacturing issues, supporting technology transfers, and driving continuous process improvements across GMP facilities. Collaborates with Manufacturing, Quality, Engineering, and Validation teams to ensure product quality, process robustness, and regulatory compliance. Mentors staff, monitors critical process parameters, authors technical documentation, and supports lifecycle management of manufacturing equipment. Requirements: Bachelor's degree with 12+ years (or MS/PhD with 10+ or 8+ years), experience in biopharma manufacturing, deep expertise in mammalian cell culture and gene therapy processes, GMP validation knowledge, and strong troubleshooting skills. Preferred: experience with triple transfection, process transfer, operational excellence initiatives. HighValue: gene therapy (platforms including triple transfection), upstream bioprocessing, GMP manufacturing, process validation, regulatory interactions, Durham, NC onsite role. WorkSetup: on-site in Durham, NC.