Process Chemist - Thermo Fisher Scientific
- 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:
- 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. Liase with Thermo Fisher Global Toxicology services/ process safety laboratory as required.
- Provide technical support to hazardous operations assessments for new process/ process changes.
- Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements.
- Participate fully 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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