Tech Transfer Lead
About The Position
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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description What You'll Do
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
- Ability to discern audible cues.
- Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
Nice To Haves
- 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
Responsibilities
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
