This multinational pharmaceutical and biotechnology corporation is one of the largest producers of therapeutics in the world with north of 50,000 employees and revenues north of 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 and headcount repsonsible for the organisations contract manufactured product portfolio. As a result of additional CMO's coming online, this leader now has a requirement for a remote working, senior end contractor within the organisations 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 Global Tech Transfer Teams and associated sub teams as required, including API sites, CMOs, DP sites, DP SMEs, CMC, ESQ, EHS, ES, others, providing the 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 activity, responsibility for action tracking, reports, meeting minutes, presentations and status communication
- Investigate problems that occur during transfer, scale up of the Process and recommend solutions
- Detailed technical analysis of transferring API Processes, Quality documents etc comparing CMO proposals; writing and reviewing all process related documents, including Technical Reports.
- Lead quality issues investigation at CMO sites where they may arise in the areas of chemistry, processing or analytical related to product quality, or where significant supply challenges, compliance or financial challenges might occur.
- Be a reliable point of contact for team members and other colleagues therefore contributing to the clear and precise communication within the Project Team
- Responsible for process validation activities and project management requirements; review finished goods specifications
- Work with multifunctional team in solving Technical Transfer related problems (when needed)
- Manage Cost Improvement Projects (CIP's) directed at reducing costs of API's 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
- Bachelor's Degree in Chemistry, Chemical Engineering or related scientific discipline. Advanced degree preferred, with broad post-Bachelor's experience relevant to the pharmaceutical industry. Ideally, a 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 organizing, 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