I am currently recruiting for a Senior Analytical Scientist to join our Cork based well-established and growing Biopharma client. This is a Senior role that will join the QC function and lead projects on site.
· Applies advanced level of understanding of analytical methods.
· Selects appropriate methods and techniques in performing methods development.
· Independently plans and executes experiments that support routine & non-routine development activities and project goals.
· May create API or drug product specifications.
· Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
· Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
· Works independently and determines methods and techniques on new or difficult assignments.
· Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
· 10 + years experience in a similar role
· Method Validation, Project Management and Analytical instrumentation experience
· Working knowledge of GMPs, pharmacopoeial, regulatory requirements for analytical testing, phase appropriate standards for method validation.
· Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
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