Tech Transfer Lead

Fujifilm•Holly Springs, NC

12d

About The Position

Position Overview 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

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

Nice To Haves

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

Responsibilities

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