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|Job Type:||Permanent||Salary:||Not Disclosed|
Our client is an establish biologics processing facility with a strong pipeline of projects and one which holds a key place in the parent organisation’s global supply network.
• Lead and develop a small group of scientists supporting commercial manufacture of products while using analytical science to help drive continuous process improvement both in analysis and manufacture of these products
• Represent the unit as a team lead for commercial products, driving strategy and insuring continued supply of product by partnering across disciplines
• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
• 3+ year's pharmaceutical/biotech experience in process and product development and analytical method development
• Strong understanding of commercial production of biological products
• Experience with regulatory filings and commercial quality systems
• Developing and implementing methods for in-process testing, process characterization, and release testing
• Experience in working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control
• Experience with QbD and PAT, as applied to pharmaceutical development
• Experience managing and transferring commercial production and testing methods
• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
Contact Brian Christensen on 01 6854747 or submit your CV to email@example.com for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747