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Salary: USD 89,600 - 166,400 / annual
DTX Pharma, a Novartis Company, is seeking an Engineer in Manufacturing Science & Technology (MS&T) to support and improve aseptic fill-finish manufacturing operations in Durham, NC. This is an onsite role focused on sterile drug product manufacturing.
You will monitor and analyze process performance data to support continued process verification and product quality. You'll lead technical investigations and provide scientific expertise to resolve manufacturing process challenges, trend critical quality attributes and process parameters to identify risks, and drive improvements. Key responsibilities include supporting technology transfer activities for new products and processes into commercial manufacturing, identifying and implementing continuous improvement opportunities, and partnering with Quality teams to maintain compliant and inspection-ready manufacturing environments.
You will collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply, support process changes with cross-functional Engineering, Validation, and Operations teams, and contribute to the startup and implementation of new equipment, software, and manufacturing processes. Additional duties include providing technical support for strategic projects, remediation initiatives, and process optimization efforts.
Required qualifications: Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or related technical field with 4+ years of biopharmaceutical GMP manufacturing experience including aseptic fill-finish operations; OR 3+ years of direct Novartis Gene Therapies experience with aseptic fill-finish operations; OR Master's degree in related technical field with 2+ years of relevant aseptic fill-finish or engineering experience.
You must have knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles. Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations is essential. Strong technical writing skills and proven ability to collaborate across cross-functional teams are required. Up to 10% travel may be required.
