Our client, an API centre of excellence of an international company, is seeking to recruit a Senior Technology Chemist, on a permanent basis.
• Provision of technical support to the manufacture of APIs and Intermediates. Serve as subject matter expert (SME) on the site’s products
• Collaboration with R&D to support the development and the technology transfer of new drug candidates to commercial sites. Act as a key team member in the transfer for a new drug substance throughout the tech transfer lifecycle from planning, process performance and regulatory support.
• Driving process robustness performance through process capability analysis and assessment. Use of this information and knowledge to contribute to comprehensive process verification reports and identifying and executing process robustness improvement projects, where required.
• Providing technical leadership in the understanding of root causes for out of trend or out of specification results or deviations through application of standard tools.
• Application of Lean tools and techniques to improve processing efficiency such as throughputs and yields.
• Maintain focus on industry and technology trends and opportunities. Champion new technology for process understanding/Monitoring. Maintain/develop links with external networks including Universities & Industry groups.
• Provide coaching, technical oversight and support for the activities of other chemist with the department. Support the development of other chemists on-site.
• PhD in Synthetic Organic Chemistry (essential).
• 7+ years of Pharmaceutical experience (essential).
• Experience of CMC regulatory requirements for pharmaceutical products and QbD
• Experience in defending processes, procedures and investigations during inspections
• Understanding of statistical process analysis and control methods.
• Subject matter expertise in crystallization process development
Contact Brian Christensen on 01 6854747 or submit your CV to email@example.com for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747