Tech Transfer Project Manager (Port Elizabeth) at Aspen Pharma Group

Description

• 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

Requirements

• 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