Process Science Tech Transfer Project Lead

Overview

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 solutionsto 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 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

Major Accountabilities

• 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

Minimum 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 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

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 .

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

PHYSICAL REQUIREMENTS PHYSICAL DEMANDS

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

WORKING ENVIRONMENT PHYSICAL DEMANDS

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes

Ability to stand for prolonged periods of time. X No Yes

Ability to sit for prolonged periods of time. X No Yes

Ability to conduct activities using repetitive motions that include writs, hands and / or fingers. No X 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

ENVIRONMENTAL CONDITIONS

Will work in warm / cold environments. X No Yes

Will work in outdoor elements such as precipitation and wind. X No Yes

Will work in small and / or enclosed spaces. X No Yes

Will work in heights greater than 4 feet. X No Yes

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