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.
Key Responsibilities:
* 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.
Our mission is to 'produce and deliver life-changing therapies that improve patient outcomes and save lives'. The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years.
Minimum Requirements:
* 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.
* Expertise in crystallisation and particle engineering.
* 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.