Description
Global Healthcares External Manufacturing site, is seeking to recruit an MT Manager (Drug Product), on a permanent basis, for our Manufacturing Technology group based in Dublin.The Manufacturing Technology group is responsible for the provision of technical expertise in the areas of Actives and Intermediates, Drug Product, Sterile Manufacturing and Packaging for small molecule products manufactured by third parties for BMS.
The MT Manager role requires significant, demonstrable experience of manufacturing processes relating to Oral Solid Dosage Manufacture and Sterile Manufacturing.
Key responsibilities
- Provision of ongoing technical support and oversight for a portfolio of externally manufactured products, 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 ensure timely, 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.
- Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for OSD 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.
Key Skills and Experience
- Demonstrated project management and technical leadership capability.
- Hands-on process management experience of all aspects of oral solid dosage commercial manufacturing processes.
- Subject Matter Expert in oral solid dosage formulation, process development, process management and trouble shooting, process robustness improvement.
- 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.
- Confident management of internal and external stakeholder relationships.
- Strong communication and negotiation skills are required for this position as well as the ability to translate technical issues into business impact and relevant solutions.
- Experience as the technical lead on Drug Product Technical Transfer projects.
- A third level degree in a pharmaceutically relevant science is required as a minimum. A Masters or PhD is preferred.
The position will require varying levels of travel - estimated at 25%
Market leading Salary and benefits package is on offer with this role.
Respond ASAP with an up to date CV for immediate consideration.
Not sure yet??? Contact me to hear more Anna Mooney .