Provide process chemistry support for existing and new processes.
Acquire and maintain a detailed knowledge and understanding of the chemistry of the relevant processes including:
Mechanisms. Development History, including boundary conditions. Impurity formation and control.
Support laboratory troubleshooting/investigative activities. Be responsible for the completion of laboratory development projects on schedule for the relevant process/es. Actively contribute to development initiatives such as those required to improve process understanding, process control, process capability, adaptability, yield and throughput. Lead/participate in thorough technical risk assessments for plant changes/product introduction. Provide technical support for Capital engineering projects relating to new customer products, existing products, and major process re-development. Prepare technical documentation to support manufacturing, e.g. Manufacturing Batch Records, laboratory SOP’s, process steps, PQ protocols, PQ reports, technical training material etc. Provide training to the Operations team personnel as necessary. Manage and seek approval for all technical changes for the product and ensure that this is appropriately communicated or raised on-site and to the relevant client. Close out all planned change notifications in a timely fashion. Ensure all process changes made have safety and quality considerations as core attributes. Carry out vital investigations of all quality and yield issues and ensure all deviation reports are closed out in a timely fashion. Liaise with customers to ensure all customer issues are dealt with, e.g. project updates, specific customer packaging requirements, specifications, technical issues as they arise. Liaise with procurement to support procurement cost reduction and security of supply projects. Provide technical support to the evaluation and assessment of suppliers. Actively participate or lead and coordinate the site input into the Technology Transfer process from clients/other Thermo Fisher sites ensuring that the processes/technologies involved are suitable for commercial production on the site. Provide chemistry feedback to customers on early phase NCE’s. Provide technical input to client regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits. Ensure all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product. Provide technical input to supplier selection, supplier change controls, audits and or technical investigation on suppliers site. Prepare tax credit assessments for relevant products. Good interpersonal and organisational skills. Be flexible and able to adjust to the business needs in a fast pace CDMO environment. Good facilitation and presentation skills. Innovative, with the potential for scientific leadership. A good teammate, able to work confidently in teams in a multi-disciplinary environment and connect with customers. Perform duties in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements. Read and understand Standard Operation Procedures applicable to role. Report all accidents, incidents and any EHS issues using the appropriate process/system to your line manager or, if required, the Occupational Health Advisor. Perform safety assessments on all new material/processes introduced to site to maintain safe operation. Liaise with Thermo Fisher Global Toxicology services/process safety laboratory as required. Provide technical support to hazardous operations assessments for new process/process changes. Participate fully in site quality initiatives and ensure that all relevant quality standards are adhered to. Maintain GMP standards where appropriate to the role. Read and understand relevant Standard Operating Procedures, Global Standard Operating Procedures and Quality standards applicable to role. Read and understand Management Policies relevant to job role. Attend training and complete assessments as required. Ensure compliance with cGMP, FDA and other quality regulatory agencies. Ensure Quality and GMP are at the forefront of changes proposed.
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Mechanisms. Development History, including boundary conditions. Impurity formation and control.
Support laboratory troubleshooting/investigative activities. Be responsible for the completion of laboratory development projects on schedule for the relevant process/es. Actively contribute to development initiatives such as those required to improve process understanding, process control, process capability, adaptability, yield and throughput. Lead/participate in thorough technical risk assessments for plant changes/product introduction. Provide technical support for Capital engineering projects relating to new customer products, existing products, and major process re-development. Prepare technical documentation to support manufacturing, e.g. Manufacturing Batch Records, laboratory SOP’s, process steps, PQ protocols, PQ reports, technical training material etc. Provide training to the Operations team personnel as necessary. Manage and seek approval for all technical changes for the product and ensure that this is appropriately communicated or raised on-site and to the relevant client. Close out all planned change notifications in a timely fashion. Ensure all process changes made have safety and quality considerations as core attributes. Carry out vital investigations of all quality and yield issues and ensure all deviation reports are closed out in a timely fashion. Liaise with customers to ensure all customer issues are dealt with, e.g. project updates, specific customer packaging requirements, specifications, technical issues as they arise. Liaise with procurement to support procurement cost reduction and security of supply projects. Provide technical support to the evaluation and assessment of suppliers. Actively participate or lead and coordinate the site input into the Technology Transfer process from clients/other Thermo Fisher sites ensuring that the processes/technologies involved are suitable for commercial production on the site. Provide chemistry feedback to customers on early phase NCE’s. Provide technical input to client regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits. Ensure all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product. Provide technical input to supplier selection, supplier change controls, audits and or technical investigation on suppliers site. Prepare tax credit assessments for relevant products. Good interpersonal and organisational skills. Be flexible and able to adjust to the business needs in a fast pace CDMO environment. Good facilitation and presentation skills. Innovative, with the potential for scientific leadership. A good teammate, able to work confidently in teams in a multi-disciplinary environment and connect with customers. Perform duties in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements. Read and understand Standard Operation Procedures applicable to role. Report all accidents, incidents and any EHS issues using the appropriate process/system to your line manager or, if required, the Occupational Health Advisor. Perform safety assessments on all new material/processes introduced to site to maintain safe operation. Liaise with Thermo Fisher Global Toxicology services/process safety laboratory as required. Provide technical support to hazardous operations assessments for new process/process changes. Participate fully in site quality initiatives and ensure that all relevant quality standards are adhered to. Maintain GMP standards where appropriate to the role. Read and understand relevant Standard Operating Procedures, Global Standard Operating Procedures and Quality standards applicable to role. Read and understand Management Policies relevant to job role. Attend training and complete assessments as required. Ensure compliance with cGMP, FDA and other quality regulatory agencies. Ensure Quality and GMP are at the forefront of changes proposed.
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