Process Development Specialist

Process Development Specialist

The Process Development Specialist will provide technical support for the development and optimization of existing and new processes. Key responsibilities include acquiring and maintaining knowledge of the chemistry of relevant processes, supporting laboratory troubleshooting activities, completing laboratory development projects on schedule, contributing to development initiatives, leading/participating in technical risk assessments, providing technical support for Capital engineering projects, preparing technical documentation, training Operations team personnel, managing technical changes, ensuring safety and quality considerations, carrying out vital investigations, liaising with customers, participating in the Technology Transfer process, providing chemistry feedback, providing technical input to client regulatory submissions, ensuring Product Quality Lifecycle Management, and performing duties in a compliant manner.

• Develop and optimize existing and new processes to ensure efficient and safe production.
• Acquire and maintain a detailed knowledge and understanding of the chemistry of the relevant processes including mechanisms, development history, impurity formation and control.
• Support laboratory troubleshooting/investigative activities to identify and resolve process-related issues.
• 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.
• Closing out all planned change notifications in a timely fashion.
• Evaluate 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.
• Participating or leading and coordinating the site input into the Technology Transfer process from clients/other 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.
• Providing technical input to client regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
• Ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product.
• Ensure seamless integration with cross-functional teams across the organization.

• Strong understanding of process chemistry principles and laboratory operations.
• Excellent analytical, problem-solving and communication skills.
• Ability to work independently and collaboratively as part of a team.
• High level of organizational and time management skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).]

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Collaborative and dynamic work environment.
• Flexible working arrangements.

Thermo Fisher Scientific is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees. If you require any accommodations during the hiring process, please let us know.