Sr. Tech Transfer Lead (Drug Product)

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:

Overview

The tech transfer role (drug product) 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.

External US

What You'll Do:

• Provides oversight on all aspects of technology transfer (TT) programs with key stakeholders, in partnership with program management
• Develop process performance qualification (PPQ) strategies and master plans specific for each program, in collaboration with internal stakeholders and customers
• Develops project plans that integrate with other scheduling functions within the organization and in alignment with program scope
• Escalates risks and tracks milestone progress and ensures cross functional communication to key stakeholders
• Manages Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, including coordination and input to customer regulatory filings
• Leads the technical team with investigating project challenges with risk assessment tools and techniques, as needed
• Provides oversight on the execution of process trends and process verification plans
• Reviews and documents process performance and product health through process trending, monitoring, and supporting annual product reviews
• Serves as the point of contact to customer and internal regulatory team for technical aspects of the process and program
• Identifies continuous improvement opportunities
• Leads best practices for TT and PPQ strategies globally, as required
• Facilitates training for manufacturing staff
• Facilitates delivery of documentation for internal and external use, such as comprehensive written manufacturing protocols and reports summarizing investigations, studies, and projects
• Develops overall process validation strategies and oversees execution of manufacturing process validation manufacturing runs
• Writes, reviews, and approves standard operating procedures (SOPs)
• Facilitates product risk assessments for new manufacturing processes
• Writes documentation for internal and external use, such as manufacturing campaign summary reports, PPQMP (Process Performance Qualification Master Protocol and reports, impact assessments, etc.
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Leads continuous improvement projects, in partnership with manufacturing, Quality, Engineering, and global teams when applicable, to improve manufacturability, reliability, yield and cost
• Deploys and maintains Large-Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements
• Other duties, as assigned

Minimum Requirements:

• Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience (e.g.,
  manufacturing); or
• Master's degree with 6 years of experience; or PhD with 3 years of experience
• Drug Product Experience Required

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

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).