Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The Tech Transfer Lead of Drug Product (DP) manages and coordinates activities for products transferred into a large-scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification and commercial). This includes managing communication and tasks between different teams, ensuring compliance with regulations, optimizing processes for efficient transfer of knowledge and technology, and other routine Manufacturing Science and Technology (MSAT) activities.

What You’ll Do

• Leads and supports technology transfer (TT) across multiple unit operations in drug product including formulation, filling, and visual inspection
• Coordinates and leads regular meetings for TT programs with key stakeholders (e.g., client meetings)
• 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 ensures 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 improvement 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, Process Performance Qualification Master Protocol (PPQMP) 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
• Creates and monitors change controls
• Reviews and approves Master Batch Records (MBR) utilizing Manufacturing Execution System (MES)
• Investigates product deviations and changes to a manufacturing process
• Other duties, as assigned

Basic 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 experience leading GMP tech transfers
• Prior drug product MSAT, Process Science, Process Engineering experience (e.g., process validation, transfer, commercialization, 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 CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.     

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.