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Lead Process Technology Transfer Specialist

2 months ago

Holly Springs, Georgia, United States Intellectt Inc Full time

Key Responsibilities

  • Oversees and facilitates the transfer of technology across various operational units.
  • Organizes and directs regular discussions for technology transfer initiatives with essential stakeholders.
  • Creates tailored process performance qualification (PPQ) strategies for each initiative in partnership with internal teams and clients.
  • Formulates project timelines that align with other scheduling activities within the organization and correspond with the program's objectives.
  • Identifies potential risks and monitors progress on milestones while ensuring effective communication among cross-functional teams.
  • Assists in Chemistry, Manufacturing, and Control (CMC) tasks for both development and production as necessary.
  • Collaborates with the technical team to address project challenges utilizing appropriate risk assessment methodologies.
  • Evaluates and documents process performance and product integrity through trend analysis, monitoring, and supporting annual product evaluations.
  • Acts as the primary liaison for customers and internal regulatory teams regarding the technical components of the program.
  • Recognizes opportunities for continuous improvement.
  • Promotes best practices for technology transfer and PPQ strategies on a global scale as needed.
  • Plans, coordinates, and supports validation runs for manufacturing processes.
  • Conducts technical risk assessments for new manufacturing methodologies.
  • Contributes to the management of manufacturing data, including databasing and statistical analysis for process monitoring and ongoing verification.
  • Prepares documentation for both internal and external purposes, such as summaries of manufacturing campaigns, Process Performance Qualification Master Protocols (PPQMP), impact assessments, and related reports.
  • Utilizes new insights to make informed, data-driven decisions promptly.
  • Collaborates with the manufacturing department to assist in both commercial and clinical production campaigns.

Essential Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or Chemical Engineering with a minimum of 5 years of relevant experience in manufacturing.
  • Master's degree with at least 3 years of experience; or
  • PhD with no prior experience.

Desirable Qualifications

  • Experience in a Good Manufacturing Practices (GMP) environment.
  • Previous experience in drug substance manufacturing, including process validation, transfer, commercialization, and troubleshooting.
  • Familiarity with quality systems such as deviation management, change control, and corrective and preventive actions (CAPA).
  • Experience with root cause analysis (RCA) and risk management tools.