Senior Chromatography Scientist for Pharmaceutical Research

2 months ago


Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time
About the Role

We are seeking a highly skilled Senior Chromatography Scientist to join our Quality Control (QC) team at FUJIFILM Diosynth Biotechnologies in Hillerød, Denmark.

As a key member of our QC Chromatography team, you will be responsible for scientifically leading chromatographic assays performed in QC Chromatography. This includes support in relation to testing, improvements, troubleshooting and investigations in compliance with cGMP.

Key Responsibilities
  • Scientific leadership on chromatographic assays performed in QC Chromatography, including support in testing, improvements, troubleshooting, and investigations in compliance with cGMP.
  • Laboratory support if unexpected analytical method trends are observed.
  • Author technical protocols and reports, e.g., implementation of new control material for FDBD-owned methods.
  • Responsible for product-specific qualification in relation to testing when transferring new products to our manufacturing facility.
  • Daily QC manager approval of test results for commercial products.
  • Handling deviations, invalid assays, laboratory exceptions, CAPAs, and change controls.
  • Ensure compliance with cGMP and be the key SME during audits and inspections.
  • Be the QC SME/project lead in close collaboration with our Analytical Development department when transferring new methods for testing in QC laboratories.
About You

The ideal candidate holds a master's degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar and has preferably a PhD combined with experience from the pharmaceutical industry.

You are experienced working under cGMP and preferably experienced with HPLCs/UPLCs and chromatography analyses. Large-scale manufacturing knowledge is an advantage as well as knowledge of regulatory requirements and ICH guidelines.

We are looking for a person who has the right attitude and dedication and understands the requirements in a cGMP QC laboratory. Someone who can handle a busy environment with many changing priorities without losing their good mood and overview and still paying attention to details.

Salary: Estimated €80,000 - €110,000 per year, depending on qualifications and experience.



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