Tech Transfer Project Manager
3 months ago
Lead and control the transfer of manufacturing processes, documentation, and expertise, between development and manufacture, or between manufacture sites
- Ensure a documented, planned approach is followed, using trained, knowledgeable personnel, with documentation of data covering all aspects of development, production, and QC
- Provide post-transfer support and facilitate communication
**Planning and project administration**
- Identify and recommend new solutions to improve tracking, planning and collaboration
- Create, maintain, and execute transfer protocols, project plans and timelines and develop solutions to execute these
- Lead technology transfer team activities and projects
- Prepare, review and present transfer proposals, status reports and track document approval
- Manage document exchange (during and post transfer)
- Contribute to regulatory filings
- Ensure that timelines are agreed and adhered to, and information, methods and materials are communicated and utilized during manufacturing
**Project communications**
- Ensure robust information exchange and coordination, alignment of goals, and understanding between sending & receiving units
- Identify project risks / issues and provide guidance to resolve them
**Project management**
- Manage the entire tech transfer project life cycle, including:
- Transfer of development and production (processing, packaging, and cleaning)
- Transfer of analytical methods for QA and QC
- Skills assessment and training
- Organization and management of the transfer
- Assessment of premises and equipment
- Documentation
- Qualification and validation
- Execution and tracking
**Risk management**
- Conduct feasibility and risk assessments
- Ensure project planning encompasses quality and risk aspects
- Ensure regulatory compliance throughout tech transfer processes
- Lead/facilitate investigations associated with tech transfer activities
**Skills Required**:
**Background/experience**
- 6 to 8 years’ experience, with at least three years in a pharmaceutical manufacturing environment and two years’ project management experience
- Demonstrated ability to lead people and processes
- Knowledge of Pharmaceutical technical issues, manufacturing processes and operations environment
- Knowledge of validation, regulatory affairs, R&D, and new product transfer
- Bachelor’s degree in pharmacy, Engineering or similar
- Project management certification would be advantageous
**Specific job skills**
- Excellent project management capability
**Competencies**
- Interpreting and Internalizing Information
- Offering Insights
- Investigating Possibilities
- Taking Action
- Information Gathering
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