Analytical Development Expert

Analytical Development Expert

Grünenthal Group

Aachen, Germany

What the job looks like

Each day you’ll enjoy a variety of challenges, such as:

  • Supervision and coordination of analytical development projects;coordination of internal and external project activities for release of APIs and pharmaceutical formulations
  • Monitoring, review and evaluation of project-related documents according to GMP-guidelines
  • Development and continuous optimisation of analytical methods in collaboration with the laboratory's technical staff
  • Coordination of external CDMOs
  • Scientific and technical support for the LATAM commercial product portfolio
  • Scientific management of projects for the clarification, quantification of genotoxic impurities and establishment of the required analytical methods, in-house or in cooperation with specialised external laboratories, for the Grünenthal portfolio
  • Preparation of dossier chapters on pharmaceutical quality with analytical content (IMPD, CTD, IND) for applications for clinical studies and marketing authorisations
  • Transfer of analytical methods
  • Creation and review of standard operating procedures (SOP)
  • Initiating the implementation and approval of specifications in the LIMS

What you’ll bring to the table

To make the most of this role and truly thrive, you should have:

  • Successfully completed studies as a chemist or pharmacist or equivalent
  • Professional experience in analytical drug development (analytical method development, validation, troubleshooting)
  • Experience with the preparation of dossier chapters (IMPD, CTD, IND) for clinical trial applications and marketing authorisations
  • Hands on experience in GMP regulated environment
  • Proven expertise in instrumental analysis
  • Fluent written and spoken English, German is a plus

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