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Job Description:
OBJECTIVES/PURPOSE :
- Manages technical topics related to the global manufacturing of Drug Product within the scope of VBU Manufacturing Science & Technology.
- Independently develops and implements continuous improvement activities for current and future manufacturing sites within the Takeda vaccines manufacturing network and drives change at internal and external sites.
- Leads resolution of technical issues related to complex Drug Product manufacturing issues and provides technical leadership related to investigations and CAPA, change controls, and during Health Authority inspections.
- Leads technology transfer activities within the scope of Drug Product manufacturing.
- Effectively partners with development, manufacturing, engineering, and quality partners in cross-functional governance meetings.
Champion the integration of AI and digital tools into manufacturing troubleshooting and decision-making.
SCOPE :
- Lead technology transfer projects for vaccine drug products across internal and external manufacturing sites.
- Co-own/develop and drive process validation strategy, including PPQ, CPV, and lifecycle management planning.
- Serve as technical SME for pertinent drug product process stages, e.g., formulation, aseptic filling, lyophilization and/or terminal sterilization, visual inspection and packaging operations processes.
- Design and execute engineering studies and scale-down models for process characterization.
- Lead risk assessments (e.g., pFMEA), deviation investigations, and CAPA implementation.
- Define and manage user requirements for new equipment and participate in qualification activities.
- Collaborate with global stakeholders (CMC, Regulatory, QA, QC, Supply Chain) to ensure alignment and readiness.
- Provide oversight and technical support during health authority inspections and audits.
- Mentor junior engineers and contribute to technical training and capability building.
- Evaluate and implement new technologies and digital tools to enhance process robustness and efficiency.
- Leverage AI and machine learning tools at disposal to analyse large-scale process data for trend identification, predictive maintenance, and anomaly detection.
- Utilize AI-driven modelling and simulation platforms to support process characterization, scale-up, and optimization.
- Work with and support implementation of digital twins and smart analytics to enhance real-time process monitoring and control strategies.
- Collaborate with data science teams to develop custom algorithms for process improvement and deviation prediction.
- Integrate AI-based decision support systems into technology transfer and lifecycle management workflows whenever feasible.
- Promote adoption of automation and intelligent systems in documentation, reporting, and regulatory submissions.
- Stay current with emerging AI technologies relevant to pharmaceutical manufacturing and assess their applicability to vaccine drug product operations.
- Leverage AI and machine learning tools at disposal to analyse large-scale process data for trend identification, predictive maintenance, and anomaly detection.
- Utilize AI-driven modelling and simulation platforms to support process characterization, scale-up, and optimization.
- Work with and support implementation of digital twins and smart analytics to enhance real-time process monitoring and control strategies.
- Collaborate with data science teams to develop custom algorithms for process improvement and deviation prediction.
- Integrate AI-based decision support systems into technology transfer and lifecycle management workflows whenever feasible.
- Promote adoption of automation and intelligent systems in documentation, reporting, and regulatory submissions.
- Stay current with emerging AI technologies relevant to pharmaceutical manufacturing and assess their applicability to vaccine drug product operations.
Locations:
Telangana, Virtual
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
