Process Science Tech Transfer Lead

Overview

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 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

PHYSICAL REQUIREMENTSPHYSICAL DEMANDSWill work in environment which may necessitate respiratory protection X No YesMay 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 YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No YesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc.

X No YesAbility 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 YesAbility to operate machinery and/or power tools. X No YesAbility 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 YesENVIRONMENTAL CONDITIONSWill work in warm/cold environments. X No Yes Will work in outdoor elements such as precipitation and wind. X No YesWill work in small and/or enclosed spaces.

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