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Reports to: Manufacturing, Science & Technology (MS&T) or Technical Operations or Operating Unit Team Leader Main Purpose and Objectives of Position: The Process Chemist is responsible for all the technical aspects of the production processes at Eli Lilly S.A. – Irish Branch. Specifically, the Process Chemist will provide support for a number of the following services at any given time: (i) Optimises the production processes to increase yield/quality, reduce manufacturing costs etc. of both new and existing processes at all stages of a product life cycle but more critically in the earlier years. (ii) Troubleshoots current manufacturing processes to maintain yield and quality as well as ensuring that the processes remain in a validated state. (iii) Transfers new processes/technology from other corporate plants and/or third party laboratories to Eli Lilly S.A. – Irish Branch. (iv) Transfers older processes/technology (outsources) from Eli Lilly S.A. – Irish Branch to other corporate plants or third party laboratories. Scope: Per above Personal Considerations: As the Kinsale site operates on a 24/7 basis, the job may involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to conduct process schools etc. Because of the critical importance of new products to the site, it is envisaged that the Process Chemist may be required to spend an amount of time working with his/her counterparts in the development/third party site prior to transfer of the process to Kinsale. Educational Requirements: PhD in Organic Chemistry License/Certificate Requirements: PhD in Organic Chemistry Language Requirements: Proficient in English Key Responsibilities: In line with the job role outlined above, the following are typically the key tasks and outcomes that would be expected of the Process Chemist: (i) Optimisation of New/Existing Processes: (a) Identify, prioritise and complete lab model on development opportunities for new or existing products based on EVA (Economic Value Added) and other criteria. (b) Be familiar with and capable of conducting experimental design approaches to project development. (c) Have intimate knowledge of regulatory requirements, including drug product critical needs. (d) Document and report all improvement activities, including plant trials. (e) Collaborate with other sites on development activities for common products. (f) Represent the Kinsale site at product conferences, planning sessions etc. (g) Identify resource and equipment needs required to facilitate development opportunities. (h) Be familiar with other competitor companies' approaches to process development and modify local approach as required to improve existing process. (ii) Maintain/Troubleshoot Existing Processes: (a) Be active member of PFT conducting process schools etc. to transfer knowledge to operations personnel. (b) Have expertise in root cause analysis to lead team in troubleshooting efforts. (c) Be very familiar with site quality systems, change control, deviation reporting, annual product reviews, quarterly product process assessments, stability, homogeneity etc. (d) Be expert on processes, know chemistry in detail, and monitor key quality indicators on an ongoing basis using SPC principles. (e) Must be familiar with process impact on other areas e.g. Safety, Environmental, Industrial Hygiene etc. (f) Develop working knowledge of engineering principles with regard to equipment, process control systems, cleaning, the impact of scale up etc. (g) Own the manufacturing ticket, process flow document and validation of the process. (h) Leading or contributing to PHRs and Risk Assessments, identifying actions/countermeasures, tracking actions/countermeasures. (i) Evaluating and Approving Process Safety Information (PSI) and Developing and approving operating procedures and tickets which include process safety requirements (iii) Technology/New Process Transfer: The Process Chemist will be the expert on the process and will be expected to do the following: (a) Be intimately familiar with the expectations of Kinsale's New Product Introduction Process (NPI) across all the dimensions. (b) Be the expert on the new product chemistry, in terms of raw material quality, development history, molecule control strategy, process safety, related substances, impurities and degradation of products etc. (c) Collaborate and work on developing the new process for Kinsale with the development groups. (d) Key contact in transferring new process information to other areas of the site. (e) Complete validation package in timely manner, prior to shipping the product off-site. (f) Review experience of New Product Introduction and document improvements. (g) Communicate project status to team and site management using key measures. (h) Co-ordinate/develop robust lab model for new processes. (iv) Outsourcing: (a) Provide in a timely manner package of information to outsource partner identifying critical process and engineering data to allow successful technology transfer to take place. (b) Be the key link in terms of communication between Eli Lilly S.A. – Irish Branch and outsource partner. (c) Spend short periods of time on third party site to transfer technology. (d) Provide ongoing consultancy to outsource partner as required. In carrying out his/her responsibilities, the Process Chemist is expected to work very closely with the Chemical Engineers and Process Control Engineers. Ideally, they will work as a team but the responsibility for the process operating conditions as specified in the manufacturing protocol is the responsibility of the Process Chemist. He/she must have the interpersonal skills required to work effectively with a broad spectrum of people.
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Eli Lilly S.A. - Irish Branch, a Swiss company with a branch office registered in Ireland under company registration number 902873 and having its Irish registered office at Dunderrow, Kinsale, Co. Cork.
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