In this role the successful candidate will provide technical support for production across various API facilities on site, including commercial production, non-commercial products (Phase III clinical), New Product Introductions (NPI) and technical transfers.
You will work as part of the API technical group along with a high performing team of engineers and chemists to develop a deep understanding of the processes and chemistry and to optimise, troubleshoot and develop processes in line with the business strategy to ensure the highest quality of product is manufactured in the API facilities.
• Responsibility for co-ordination and oversight for process and cleaning validation.
• Responsibility and oversight for continuous process verification and associated risk assessments to develop robust processes.
• Understanding and interpretation of product regulatory filings, to ensure a high level of compliance for the processes.
• Process optimisation in order to sustain and improve product quality, yields and throughput. Making recommendations and implementing measures to improve the process in line with yields, efficiency and quality of product.
• Dynamic support to operations through process maintenance, troubleshooting and process development.
• Interfacing with new product development groups to integrate new products into the facility either as new process development entities or as product transfer from another manufacturing facility. Supporting migration of process knowledge for product technical transfers from facility.
• Identifying continuous improvement activities and leading or participating in cross-functional teams to implement. Supporting activities in the areas of cost reduction, process efficiency and operational excellence.
• Providing on-the-floor technical support to the Operations Team for process/equipment optimization and troubleshooting.
• Ensuring that all safety, quality and environmental compliance goals are achieved, including thoroughly investigating deviations and ensuring appropriate corrective actions are identified and implemented in full.
• The successful candidate will have a PhD in organic chemistry or a minimum of BSc at 2.1 with significant relevant experience.
• Ideal PHD candidate would have min. 1 years’ experience in API;
• For non-PHD candidates we would require 4 years min API experience; must have manufacturing pharma experience at a minimum.
• Excellent communication skills both verbal and written.
• A proven track record of working in cross-functional and multi-disciplinary teams.
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