Senior Process Chemist

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Description
The job:
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
At the Cork site we manufacture a number of established commercial products and are successfully engaged in New Product Introductions from various clients.
The Process Chemist will function as a key member of the Process Development Service Team. We provide process chemistry support for existing and new processes to ensure that the site’s scientific, quality and safety metrics are all achieved. We assume chemistry authority for assigned processes.

WHO WE ARE LOOKING FOR:

• Relevant qualification such as BSc; masters or PhD in chemistry or related field.
• Excellent partnership and interpersonal skills are required to interact across teams on site and with all levels of organization and clients.
• Experience in supporting API plant processes is helpful.

• Acquire and maintain a detailed knowledge and understanding of the chemistry of the relevant processes
• Lead/participate in detailed technical risk assessments for plant changes/product introduction.
• Actively chip in to development initiatives such as those required to improve process understanding, process control, process capability, cycletime, yield and efficiency.
• Actively participate or lead and coordinate input into the Technology Transfer process, ensuring that the processes / technologies involved are suitable for commercial production.
• Prepare technical documentation to support manufacturing, e.g. Manufacturing Batch Records, laboratory SOP’s, process steps, PQ protocols, PQ reports, CMC chemistry descriptions, technical training material etc.
• Provide training to the Operations team personnel.
• Lead and seek approval for process changes and ensure that this is appropriately communicated and progressed on and off-site.
• Carry out investigations of all quality and yield issues and ensure all deviation reports/unplanned change notifications and Quality Investigation Reports are closed out in a timely fashion.
• Liaise with customers to ensure all customer issues are looked after, e.g. project updates, specific customer requests
• Support the completion of laboratory development projects on schedule for the relevant process/es.
• Liaise with procurement to support procurement cost reduction and security of supply projects. Provide Scientific advice to the evaluation and assessment of suppliers.
• Provide technical support for Capital engineering projects relating to new products, existing products, and major process re-development.
• Support 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 actively maintained.

In addition to the above a Senior Process Chemist

• Is recognised as the principal point of contact for all technical aspects of a product
• Is accountable at site level and with clients for maintaining this knowledge.
• Maintains accountability throughout product lifecycle, influencing the manufacturing process, analytical process and associated specifications, including technical input to the lifecycle validation approach for the product..
• Lead in assessing the product quality impact of any change that can impact CQAs/CPPs via review and update of the product control strategy.
• Provides leadership and establishes key relationships within site across Operations, Technical, Quality and Engineering for the product(s) for which they are accountable, and off-site with customers and their technical representatives.
• Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
• Develops and trains successors for the role, and coaches’ others in their area of expertise, ensuring other functions (e.g. Operations) have sufficient understanding to complete their roles.