Fantastic opportunity for an experienced Process Development Chemist on a permanent basis to work on an extensive range of products and projects. This facility is continuing to grow with excellent career progression opportunities. The Process Chemist will provide process chemistry support for existing and new processes to ensure that the site’s scientific, quality, and safety metrics are all achieved.
Overview of Main Responsibilities:
1. Acquire and maintain a detailed knowledge and understanding of the chemistry of the relevant processes.
2. Lead/participate in detailed technical risk assessments for plant changes/product introductions.
3. Actively contribute to development initiatives required to improve process understanding, process control, process capability, cycle time, yield, and efficiency.
4. Participate or lead and coordinate input into the Technology Transfer process, ensuring that the processes/technologies involved are suitable for commercial production.
5. Prepare technical documentation to support manufacturing, including Manufacturing Batch Records, laboratory SOPs, process steps, PQ protocols, PQ reports, CMC chemistry descriptions, and technical training material.
6. Provide training to the Operations team personnel.
7. Lead and seek approval for process changes and ensure appropriate communication and progression on and off-site.
8. 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.
9. Liaise with procurement to support cost reduction and security of supply projects. Provide scientific advice for the evaluation and assessment of suppliers.
10. Provide technical support for Capital engineering projects relating to new products, existing products, and major process re-development.
11. Support submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
12. Maintain accountability throughout product lifecycle, influencing the manufacturing process, analytical process, and associated specifications, including technical input to the lifecycle validation approach for the product.
13. Provide 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.
14. Develop and train successors for the role, and coach others in their area of expertise, ensuring other functions (e.g., Operations) have sufficient understanding to complete their roles.
Minimum Requirements:
1. PhD in Organic Chemistry or related area.
2. Ideally 3+ years experience in process development, tech transfers, and NPI support.
3. Experience in supporting API plant processes is helpful.
Competitive salary (depending on experience).
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