Tech Transfer Lead

Position

Tech Transfer Lead at FUJIFILM Biotechnologies

The tech transfer role includes the management and coordination of activities for products transferred into large scale manufacturing facilities, 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.

• Lead and support technology transfer (TT) across multiple unit operations
• Coordinate and lead regular meetings for TT programs with key stakeholders
• Develop process performance qualification (PPQ) strategies specific for each program in collaboration with internal stakeholders and customers
• Develop project plans that integrate with other scheduling functions within the organization and align with program scope
• Escalate risks and track milestone progress and ensure cross‑functional communication to key stakeholders
• Support Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, as required
• Support the technical team to investigate any project challenges with necessary risk assessment tools and techniques
• Review and document process performance and product health through process trending, monitoring, and supporting annual product reviews
• Serve as point of contact to customer and internal regulatory team for technical aspects of the program
• Identify continuous improvement opportunities
• Support best practices for TT and PPQ strategies globally, as required
• Coordinate, plan, and support manufacturing process validation runs
• Facilitate technical risk assessments for new manufacturing processes
• Contribute to the management of manufacturing data (e.g., databasing) and the statistical analysis aimed at both process monitoring and continued process verification
• Write documentation for internal and external use, such as manufacturing campaign summary reports, PPQMP (Process Performance Qualification Master Protocol and reports, impact assessments, etc.)
• Interpret and utilize new knowledge to promptly drive data‑based decisions
• Collaborate with manufacturing department to support commercial and clinical manufacturing campaigns
• Other duties, as assigned

• 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
• Ph.D. with no prior experience

• 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

Ability to discern audible cues.

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

Mid‑Senior level

Full‑time

Engineering and Information Technology