About this role
At Thermo Fisher Scientific's Cork site, join a team manufacturing established commercial products and introducing new ones from clients. As a key member of the Manufacturing Technical Team, provide process chemistry support for existing and new processes to meet scientific, quality, and safety metrics. Assume chemistry authority for assigned processes.
Acquire and maintain detailed knowledge of relevant process chemistry. Lead or participate in technical risk assessments for plant changes and product introductions. Actively support development initiatives to improve process understanding, control, capability, cycle time, yield, and efficiency.
Prepare technical documentation like Manufacturing Batch Records, SOPs, and PQ protocols. Provide training to Operations team personnel and liaise with customers on project updates. Ensure adherence to Good Manufacturing Practices and safety standards in a standard Monday-Friday schedule.
Lead process changes, investigations of quality issues, and Technology Transfer processes for commercial production. Support capital projects, submissions, audits, and Product Quality Lifecycle Management. Be encouraged to perform at your best in a growing global organization investing heavily in R&D.
Requirements
- Relevant qualification such as BSc, masters or PhD in chemistry or related field
- Excellent partnership and interpersonal skills to interact across teams, organization levels and clients
- Experience in supporting API plant processes
- Detailed knowledge of process chemistry
- Ability to perform technical risk assessments
- Familiarity with GMP safety standards
- Skills in preparing CMC chemistry descriptions and technical training material
Responsibilities
- Acquire and maintain detailed knowledge and understanding of the chemistry of relevant processes
- Lead/participate in detailed technical risk assessments for plant changes/product introduction
- Actively support development initiatives to improve process understanding, process control, process capability, cycletime, yield and efficiency
- Actively participate or lead Technology Transfer process ensuring suitability for commercial production
- Prepare technical documentation including Manufacturing Batch Records, laboratory SOPs, PQ protocols and reports
- Provide training to Operations team personnel
- Lead process changes and ensure appropriate communication on and off-site
- Carry out investigations of quality and yield issues and close out deviation reports timely
Benefits
- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Range of employee benefits
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