Fantastic opportunity for an experienced Senior 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 Snr 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 (full job description available on request):
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 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.
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..
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.
What the ideal candidate looks like:·
Phd in Organic Chemistry or related area
Ideally 3+ years experience in process development, tech transfers and NPI support is beneficial.
Experience in supporting API plant processes is helpful.
What you will get in return:
Competitive salary (depending on experience)
For a confidential discussion and more information on the role, please contact Aisling Lane.