Tech Transfer Lead

The 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.

Job Description

What You'll Do

• 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
• Other duties, as assigned
  
  

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
  
  

Working & Physical Conditions

Ability to discern audible cues.

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

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.