Tech Transfer Lead Position Available In Wilson, North Carolina

Job Title:

Tech Transfer Lead Job Description The Technology Transfer Lead is a pivotal role within Manufacturing Operations, acting as a subject matter expert and collaborating closely with quality, regulatory, manufacturing, engineering, and R D teams. This position is responsible for coordinating the transfer and implementation of projects and technologies from development groups and customers to the manufacturing site. The role involves designing manufacturing processes for new or modified products to ensure robust and reliable production at a commercial scale, covering the full product lifecycle, including development, stability, validation batches, and cleaning validation/verification studies. Responsibilities Lead the execution of new product technology transfer and cleaning projects, ensuring timely and compliant delivery. Communicate plant-related issues and tasks to project teams, especially regarding scale-up, new equipment, validation, and batch manufacturing. Prepare the manufacturing site for new product introduction. Conduct risk assessments (e.g., FMEA) to design robust manufacturing processes. Act as the plant liaison for manufacturing processes across departments and external units. Draft master batch records and protocols for development, stability, and validation batches. Translate development findings into scalable manufacturing processes. Provide documentation for regulatory submissions and responses. Serve as the primary contact for manufacturing-related inquiries and resolutions. Support scale-up evaluations and technical assessments of manufacturing changes. Assist with investigations, action plans, and material change requests. Develop and execute validation protocols and investigative studies. Review technology transfer documentation with regulatory and other stakeholders. Coordinate with external customers and vendors as needed. Track and report on departmental assignments such as project time tracking and APQRs. Mentor new department employees and provide first-level support to team members. Identify and address process gaps through action plans. Essential Skills Bachelor’s degree in science, engineering, or equivalent experience. 3-5 years of experience in product development, process scale-up, or technology transfer. Strong interpersonal skills and ability to work effectively across all organizational levels. Excellent oral and written communication skills, including technical writing and presentations. Expertise in cGMP manufacturing, equipment and process engineering, quality, product formulation, sterile manufacturing, packaging, warehousing, distribution, purchasing, contracting, and enterprise systems. Additional Skills & Qualifications Proficiency in engineering and pharmaceutical processes. Experience with process development and process optimization. Familiarity with Trackwise and other enterprise systems. Work Environment The work environment is dynamic and collaborative, focusing on cutting-edge technologies and processes. You will work with cross-functional teams, ensuring compliance with industry standards. The role involves working with advanced manufacturing equipment and requires a proactive approach to problem-solving and continuous improvement.