This multinational pharmaceutical and biotechnology corporation is one of the largest producers of therapeutics in the world, with upwards of 50,000 employees and revenues above 10 billion per annum. In recent years, this market leader has expanded its footprint here in Ireland, to not only include significant manufacturing operations, but additionally has started housing a number of key global roles responsible for the organisation's contract manufactured product portfolio. As a result of additional CMOs coming online, this world leader now requires a remote working, senior end contractor within the organisation's Global Technical Group.
- Successful transfer of APIs from internal sites to CMOs, generating comparable physical and chemical quality for DP customers.
- Qualifying all identified markets and meeting the business milestones and drivers. Coordinate execution of agreed action plans to meet timelines and milestones.
- Proactively identify, communicate, and implement required project/plan issues and support the implementation of the corresponding resolution, coordinating the related action plan activity.
- Actively participate in and lead the Global Tech Transfer Teams and associated sub teams as required, including API sites, CMOs, DP sites, DP SMEs, CMC, ESQ, EHS, ES, and others, providing pharmaceutical knowledge and technical support to all technical transfer activity.
- Lead ES API source change activity and qualification of alternate CMO suppliers, building and leading cross-functional project teams, developing and maintaining project and program implementation plans, chairing meetings, scheduling of activities, responsibility for action tracking, reports, meeting minutes, presentations and status communication.
- Investigate problems that occur during transfer and scale up of the process, and recommend solutions.
- Detailed technical analysis of transferring API processes, quality documents, comparing CMO proposals, and writing and reviewing all process related documents, including technical reports.
- Lead quality issue investigations at CMO sites where they may arise in the areas of chemistry, processing, or analytics related to product quality, or where significant supply, compliance, or financial challenges might occur.
- Be a reliable point of contact for team members and other colleagues, therefore contributing to clear and precise communication within the Project Team.
- Responsible for process validation activities and project management requirements, and reviewing finished goods specifications.
- Work with multifunctional team in solving Technical Transfer related problems (when needed).
- Manage Cost Improvement Projects (CIPs) directed at reducing costs of APIs at third parties.
- Provide SME input to the ES API network to improve overall product performance in quality (Ppk) and cost, and engage with contract manufacturing organisations to ensure the successful delivery of projects, investigations, and technical issue resolution within API manufacturing.
- Bachelors degree in Chemistry, Chemical Engineering, or related scientific discipline. Advanced degree preferred, with broad post-bachelor experience relevant to the pharmaceutical industry. Knowledge of organic chemistry would be beneficial.
- Broad knowledge of technology transfer process and manufacturing for active pharmaceutical ingredients.
- Good technical understanding of pharmaceutical processes and the impact of technical change.
- Demonstrated experience and competence in organising, planning, and problem solving related to qualifying new API suppliers.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321865 for a confidential discussion.