Senior R&D Chemist
The Senior R&D Chemist will be responsible for providing strong scientific leadership for all aspects of new and existing chemical processes development, technology transfer, process scale-up, process monitoring, and process troubleshooting and optimisation for small molecules APIs and intermediates. Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and leading/supporting Continuous Improvements activities. The role will involve significant cross functional collaboration with other functions including R&D, Operations, Quality, SHE, Supply Chain, PM and external stakeholders working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control.
What will you do?
• Provision of technical support on the design, development and improvement of process chemistry routes of synthesis (including synthetic route scouting and development of second-generation processes).
• Provision of technical support to the manufacture of APIs and Intermediates manufactured at Swords
• Drive, motivate and facilitate project teams, ensuring that timelines for R&D activities in support of scheduled campaign are achieved.
• Manage a team of chemists providing technical leadership, setting high performance standard and championing team’s personal development.
• Lead laboratory work to develop or improve manufacturing processes.
• Serve as Subject Matter Expert (SME) on products manufactured on site.
• Collaborate with internal and external stakeholders to support the development and the technology transfer of processes to Swords. Act as a key team member in the transfer of new processes throughout the tech transfer lifecycle from planning, process performance and post campaign support.
• Drive process robustness performance through process capability analysis. Use of this information and knowledge to contribute to comprehensive process verification reports and identification/execution of process robustness improvement projects, where required.
• Liaise with other departments on site (Quality, Supply Chain, PM, Procurement, Operations, SHE, Finance, and Engineering) to ensure efficient and robust chemical processes are executed on site.
• Interact with customers and wider SK network on a project or campaign basis to track progress of activities, identify continuous improvement opportunities and resolve issues
• Lead or support investigations, including statistical alert events, and provide coaching to chemists on process-related issues and identification of robust CAPAs through application of standard and statistical tools.
• Lead cost reduction projects, applying Lean tools and techniques to improve processing efficiency such as throughputs and yields.
• Ensure a culture of OpEx with the group and support the OpEx projects.
• Maintain focus on industry and technology trends and opportunities. Champion new technology for process understanding/monitoring and drive innovation/improvement on existing work practice (e.g. PAT, lab automation).
• Drive the development of appropriate specialist skills within R&D.
• Maintain/develop links with external networks including Universities & Industry groups.
• Drive continuous innovation, including second generation chemistry, innovative chemistry and promote industry best practice internally.
• Provide coaching, technical oversight and support for the activities of other chemist within the department. Support the development of other chemists on-site.
• Champion safe work practice.
• Support management of R&D laboratories.
• Assist in the recruitment, integration and training of chemists.
• Support budget planning activities.
• PhD in Synthetic Organic Chemistry.
• 3+ years of experience in API process development and/or technical manufacturing support role.
• Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
• Excellent critical thinking and problem-solving abilities. Must be capable of grasping complex technical issues and making sound decisions based on the fundamental principles of the technology, the data, and applicable business and strategic issues.
• In depth knowledge of organic chemistry and chemical synthetic route development.
• Experience of CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles.
• Experience in defending processes, procedures and investigations during health authorities’ inspections is desirable.
• Understanding of statistical process analysis and control methods. Experience in using statistical software packages is desirable.
• Demonstrated capability in the use of various analytical/diagnostic tools including PAT and process safety tools is desirable.
• Thorough understanding, knowledge, and commitment to the regulatory requirements (SHE, GMP, Finance) for the R&D function.
• Ensure that GMP, Quality, SHE requirements are considered in all aspects of the role.
• Experience in leading R&D activities in the technology transfer of new processes is desirable.
• Experience in leading and managing team is desirable.
Whats in it for you?
• A chance to work with a world leader in contract development and manufacturing in a fast paced, dynamic, and growing company
• Excellent opportunities for career enhancement and personal development
• Competitive base salary