Our client is a major multinational pharmaceutical manufacturer based in Cork now have a permanent role for an API Specialist. This hire will provide technical support on manufacturing processes relating to Manufacture and oversight for a portfolio of manufactured products on site and some external manufacturers.
The successful candidate will drive the use of strategies, resources and processes (OPEX, etc.) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
The ideal candidate will have significant experience of manufacturing processes relating to the manufacture of small molecule API and corresponding intermediate materials.
Responsibilities for API Process Chemist, PhD:
Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required. Using this information and knowledge to contribute to comprehensive and accurate annual product and annual contractor reviews.
Managing technical transfers from R&D or contract manufacturing sites into manufacturing.
Technical oversight and direction for process validation
Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for API or intermediate manufacturing processes.
Preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of RFIs and RFPs.
PhD in Chemistry (Analytical, Medicinal, Organic, Synthetic, etc.)
5+ relevant industrial experience.
SME in relevant API chemistry, process development, process management and trouble shooting, process robustness improvement.
Understanding of process, engineering, analytical and regulatory aspects.
Hands-on process management experience of all aspects of small molecule API commercial manufacturing processes
Understanding of statistical process analysis and control methods. Experience in using Statistical software packages.
For further details, please contact Larry on +353 (0) 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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