We are searching for a project manager who will be the single point of contact for all analytical topics within the project (development - product discontinuation).
·Look over analytical activities and compilation of analytical documentation.
·Actively managing analytical knowledge of the project and having an overview on these activities
·Overseeing and coordinating method development, stability indicating studies, method qualification and validation, method transfer, method monitoring and improvement
·Supporting all analytical activities, defining the stability profile of the molecule and structure-function relationships
·Compiling documentation: product specifications, sampling plans, analytical method transfer protocols and reports, leachable and extractable studies
·Supporting preparation of reports of other departments (e.g. USP/DSP development and manufacturing) by providing analytical data collected in analytical departments and support interpretation of these data
·Supporting any troubleshooting activities with analytical knowledge and performing analytical activities
·Supporting preparation of regulatory submissions as well as participation in meetings with regulatory authorities as needed
·Preparation, reviewing of procedures, protocols and reports
·Communication with external companies to align on analytical tasks
If you have:
·University degree (biotechnology, analytical chemistry, biochemistry, pharmacy, or related)
·Practical and theoretical knowledge about development, transfer and validation of analytical methods, stability studies, liquid chromatography concerning work with biological drugs (such as: peptide mapping, SEC, IEC, HILIC), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopeial methods used for released raw materials, intermediates and final drug products
·5 years’ experience in regulated laboratory environment (biotech lab preferably)
· GLP and GDP knowleadge
·Project management experience
If this sounds like something which would interest you, or someone you know.
Please get in touch.