Process Technology Transfer Lead

4 weeks ago


Holly Springs, United States Intellectt Inc Full time

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)
  • 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


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