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 Sr 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.

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

Knowledge and Skills

• Builds effective working relationships internally to collaborate cross-functionally
• Ability to adapt communication style to differing audiences and advise others on complex matters
• Ability to navigate through crucial conversations
• Effective communication, both written and oral
• Ability to generate mechanistic and theoretical hypotheses
• Advanced Project Management skills
• Ability to effectively present information to others
• Strong strategic thinking skills
• Ability to remain up to date on regulatory and quality requirements for manufacturin

Basic 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

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
• Experience in Project Management

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes

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.