Sr. Manager, Automation – GTx Lead

Role: Senior Manager, Automation (GTx Lead) in biopharma manufacturing, focusing on automation systems critical for gene therapy production. Responsibilities include leading the design, implementation, and maintenance of automation platforms such as DCS, PLC, SCADA, MES, and Historian; driving continuous improvement; managing change controls and CAPAs; supporting regulatory inspections; and partnering across Engineering, Manufacturing, Quality, and Technical Operations. Requirements: Bachelor's in Engineering or related field; 9+ years' experience with IT/OT automation systems supporting GMP biologics manufacturing; expertise in process automation, regulated systems, and team leadership; strong problem-solving and communication skills; knowledge of FDA, cGMP, and health standards; proficiency with digital tools. Preferred qualifications include experience supporting complex, 24/7 biologics or gene therapy manufacturing environments, with familiarity in lifecycle management of automation systems. High-Value: biologics, gene therapies, GMP environment, regulated computerized systems, cross-functional collaboration, onsite in Durham, NC with no relocation support.