Fantastic opportunity for a Process Development Chemists to provide support to both existing and New Product introductions.
This client site is expanding and it is an exciting time to join this reputable multinational as the Cork site continues to grow.
Duties and Responsibilities:
- Acquire and maintain a detailed knowledge and understanding of the chemistry of the relevant processes
- Lead/participate in rigorous technical risk assessments for plant changes/product introduction.
- Actively contribute to development initiatives such as those required to improve process understanding, process control, process capability, robustness, yield and throughput.
- Actively participate or lead and coordinate the Cork site input into the Technology Transfer process, ensuring that the processes / technologies involved are suitable for commercial production on the Cork site.
- Prepare technical documentation to support manufacturing, e.g. Manufacturing Batch Records, laboratory SOP’s, process steps, PQ protocols, PQ reports, CMC chemistry descriptions, technical training material, etc.
- Provide training to the Operations team personnel as necessary.
- Manage and seek approval for all technical changes for the product and ensure that this is appropriately communicated or escalated on and off-site. Closeout all planned change notifications in a timely fashion.
- Ensure all process changes are adequately assessed from a safety and quality perspective
- Carry out necessary investigations of all quality and yield issues and ensure all deviation reports/unplanned change notifications and Quality Investigation Reports are closed out in a timely fashion.
- Liaise with customers to ensure all customer issues are dealt with, e.g. project updates, specific customer packaging requirements, specifications, technical issues as they arise.
- Support troubleshooting/investigative activities.
- Support the completion of laboratory development projects on schedule for the relevant process/es.
- Liaise with procurement to support procurement cost reduction and security of supply projects. Provide technical support to the evaluation and assessment of suppliers.
- Provide technical support for Capital engineering projects relating to new products, existing products, and major process re-development.
- Provide technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
- Ensure all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product.
- Provide technical input to supplier selection, supplier change controls, audits and/or technical investigation on suppliers site.
- successors for the role, and coaches others in his/her area of expertise, ensuring other functions (e.g. Operations) have sufficient product knowledge and understanding to execute their roles.
- Relevant qualification such as BSc; masters or PhD in chemistry or related field.
- Excellent communication skills are required to interact across teams on site and with all levels of organization and clients.
- Experience in supporting API plant processes is preferred.
For a confidential discussion and more information on the role, please contact Rory Walsh.