Description
Global Pharmaceutical company seeking a MT API Specialist to join there Dublin based team. This role is a permanent position with an extremely attractive salary and benefits package on offer. The role also includes 30% travel.Key responsibilities include:
- Provision of ongoing technical support and oversight for a portfolio of externally manufactured APIs, Intermediates and Starting Materials, ensuring consistent security of supply.
- Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required. Using this information and knowledge to contribute to comprehensive and accurate annual product and annual contractor reviews.
- Supporting CMO/vendor selection - preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of RFIs and RFPs.
- Managing technical transfers to contract manufacturing organizations.
- Technical oversight and direction for process validation.
- Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for API or intermediate manufacturing processes.
- Driving the use of strategies, resources and processes (OPEX etc) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
- Provide technical support for change management, investigation CAPA identification and related activities at contractor site.
Key Skills and Experience Required:
- A Masters or PhD in Chemistry (preferably synthetic organic chemistry) is required.
- Relevant industrial experience (ideally > 5 years) is essential.
- Demonstrated project management and technical leadership capability.
- Subject Matter Expert in relevant API chemistry, process development, process management and trouble shooting, process robustness improvement.
- In-depth knowledge of pharmaceutical process scale-up, tech transfer and manufacturing support (change control, investigations, process optimisation). Understanding of process, engineering, analytical and regulatory aspects.
- Hands-on process management experience of all aspects of small molecule API commercial manufacturing processes.
- Demonstrated capability in the use of standard tools for root cause analysis.
- Understanding of statistical process analysis and control methods. Experience in using Statistical software packages.
If you are interested in this great opportunity and have the appropriate skill set and experience please contact me Anna Mooney .