Process Scientist - OSD and Fill Finish

Process Scientist - OSD and Fill Finish | Cork, ie, IE

Posted 10 days ago

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Team Horizon is seeking a Process Scientist - OSD and Fill Finish for our client based in Cork. The Process Scientist will work within the Site Technology team to provide analytical support to scale-up, product support and clinical supply projects. This role will support all analytical aspects of a product’s life cycle from development through to commercial manufacturing. This role will involve working within the Site Technology team Why you should apply: * This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. * There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives. * Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: * Support and lead, scientific, engineering, and operational leadership programs for the introduction new products into the commercial facility. * Involves high levels of cross functional collaboration, technology transfer, process scale up, process performance monitoring and optimization and continuous improvement. * Act as Subject Matter Expert (SME) for fill finish operations and processe.s * The role will contribute to process understanding, manufacturing best practices for filling technology with focus on the continuous improvement. * Provide technical input to technology transfer related documents (e.g., clinical, and commercial Validation protocols, batch records). * The role will also support all aspects of new technology introduction, plant performance, process improvements, cGMP compliance and troubleshooting as part of the product support role during the commercial life span of the product. * Support the performance of validation activities deemed within the scope of Site Technology, including cleaning, laboratory equipment and process validation. * Support all aspects of a product life cycle, including development, registration, clinical and commercial manufacture. * Support the Site Technology department in meeting departmental and site KPI’s. * Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues. * Provide SME input to aseptic filling and visual inspection, including technical assistance and deviation investigation. * Manage and lead the startup activities, will provide investigational support, lead and/or contribute to STE lab studies. * Provide direction and leadership with respect to future process improvement activities * Assist in the selection of the appropriate technologies to support the product manufacture. * Support/lead the selection process for introduction of new analytical/process equipment and the process of the introduction of new methods and procedures. * Develop SOPs to support the new equipment and methods. * Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, or technologies. * Be familiar with the products, the manufacturing techniques, and procedures. * Trending of process data and correction of product issues. What you need to apply: * 3rd level technical/scientific qualification in biochemistry, Chemical, biochemical engineering, or related field with 4+ years relevant experience to Ph. D level desirable. * Aseptic drug product experience in sterile fill finish operations and/or DP visual inspection and defect library creation and maintenance is highly desirable * Ability to manage both projects and day to day activities. Ensure that priorities are effectively established and controlled. * Be able to take the necessary guidance and instruction on both cGMP and technical projects where required. * Demonstrate a commitment to identifying and improving the management processes for the effective control of the activities. * Experienced in cGMP and large-scale manufacturing equipment and practices and with the transfer of technology to cGMP operations