**Position Overview** The tech transfer role includes the management and coordination of activities for products transferred into large scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This involves managing between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology. **Job Description** **What You'll Do** •Leads and supports technology transfer (TT) across multiple unit operation • Coordinates and leads regular meetings for TT programs with key stakeholders • Develops process performance qualification (PPQ) strategies specific for each program in collaboration with internal stakeholders and customers • Develops project plans that integrates with other scheduling functions within the organization and in alignment with program scope • Escalates risks and tracks milestone progress and ensure cross functional communication to key stakeholders • Supports Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, as required • Supports the technical team to investigate any project challenges with necessary risk assessment tools and techniques • Reviews and documents process performance and product health through process trending, monitoring, and supporting annual product reviews • Serves as point of contact to customer and internal regulatory team for technical aspects of the program • Identifies continuous improvements opportunities • Supports best practices for TT and PPQ strategies globally, as required • Coordinates, plans, and supports manufacturing process validation runs • Facilitates technical risk assessments for new manufacturing processes • Contributes to the management of manufacturing data (e.g., databasing) and the statistical analysis aimed at both process monitoring and continued process verification • Writes documentation for internal and external use, such as manufacturing campaigns summary reports, PPQMP (Process Performance Qualification Master Protocol and reports, impact assessments etc. • Interprets and utilizes new knowledge to promptly drive data-based decisions • Collaborates with manufacturing department to support commercial and clinical manufacturing campaigns • Other duties, as assigned **Minimum Requirements** Bachelor’s degree in engineering, Life Science or Chemical Engineering with 5 years of relevant experience (e.g., manufacturing); or • Master’s degree with 3 years of experience; or • PhD with no prior experience **Preferred Requirements** •Experience working in a Good Manufacturing Practices (GMP) environment • Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting • Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system) • Experience with root cause analysis (RCA) and risk management tools **Working & Physical Conditions** Ability to discern audible cues. Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. _To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._ **Job Locations** _US-NC-Holly Springs_ **Posted Date** _1 week ago_ _(12/8/2025 10:07 AM)_ **_Requisition ID_** _2025-36347_ **_Category_** _Process Sciences_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_