Process Development Scientist

3 Days Old

Lead Process Scientist Drug Substance LANT
Summary & Purpose of the Position lead the process transfer of Drug Substance (DS) manufacturing process for new products from development to manufacturing ensure process knowledge and control strategies are appropriate to ensure Drug Substance processes operate in a reliable, cost effective, safe, and compliant manner ensure documentation is ready and available to support the process design Drug Substances ahead of Regulatory examination ensure any gaps in the process design and/or control strategy are identified Action any identified gaps and ensure they are closed as required prior to PPQ and commercial manufacture
Main Responsibilities & Technical Competencies Able to interrogate process monitoring and data analysis of the DS process. Identify areas of improvement or concern. Have a broad understanding of CMC activities, regulatory strategy, understand risks and be able to link actions to Manufacturing Science and Technology. SME in aspects of Drug Substance process. Presenting the review finding and proposed actions to address any gaps to stakeholders including Site Leadership team, BPD and the global MS&T team Able to perform technical/critical review of data from Drug su...
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Location:
Wrexham
Category:
Healthcare & Pharma

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