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Analytical Scientist with Validation experience for Biopharma Analytical Manufacturing Development

The position

You will be part of a group of validation scientists in the team with responsibility for transfer, optimization and validation of analytical methods for new products according to current regulatory requirements. You will prepare protocols, reports and analytical procedures and you will assist the laboratories in Biopharm with the implementation of the methods in close collaboration with the group of laboratory technicians in the team. Furthermore, you will drive projects to optimize and improve the current analytical methods in Biopharm QC and support the rest of the department with preparation of documentation for the authorities. You will have contact to a lot of colleagues outside the team and will be in close dialogue with the development departments, Biopharm QC and Quality Assurance (QA). All in all, it is a challenging and stimulating job that requires energy, drive and flexibility.

Qualifications

  • You hold a Master’s degree in Science within Pharmacy, Chemistry or a similar field
  • You have experience from a laboratory environment subject to GMP with one or several analytical techniques such as ELISA, clotting assays, SPR, CE-SDS, HPLC and/or iCIEF.
  • You have experience within validation and standardization of analytical methods and knowledge of equipment qualification is also an advantage
  • You thrive in a busy environment with an unpredictable workday where you are faced with difficult issues and also have to keep focus on the adjustment of small details
  • You are good at creating an overview and prioritizing your tasks; even when deadline approaches.
  • You never compromise on quality and at the same time you are good at completing your tasks in time and move on to new tasks with energy and enthusiasm.
  • You are a team player – openminded, engaged and able to inspire and motivate your colleagues. We expect you to possess good communication skills in both oral and written Danish and English.

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