Fujifilm Manufacturing USA, Inc

Sr. Tech Transfer Lead (Drug Product)

Fujifilm Manufacturing USA, Inc • $100K — $130K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Reposted 3 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience; or a Master's degree with 6 years of experience; or a PhD with 3 years of experience
  • Required experience in drug product
  • Experience in a Good Manufacturing Practices (GMP) environment preferred
  • Prior experience in drug substance or manufacturing, including process validation and commercialization is preferred
  • Familiarity with project management and coordination in a manufacturing context

Responsibilities

  • Oversee all aspects of technology transfer (TT) programs with key stakeholders
  • Develop process performance qualification (PPQ) strategies and master plans
  • Create project plans that align with organizational scheduling functions
  • Track milestone progress and enhance cross-functional communication
  • Manage Chemistry, Manufacturing and Control (CMC) activities
  • Investigate project challenges using risk assessment tools
  • Review and document process performance and product health

Benefits

  • Professional development and training opportunities
  • Collaborative work environment
  • Exposure to innovative drug manufacturing processes
  • Opportunity to lead continuous improvement projects
  • Engagement with global teams and stakeholders
Full Job Description
Overview

The tech transfer role (drug product) 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

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

Minimum 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
  • Drug Product Experience Required

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

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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