Senior Chromatography Specialist

4 weeks ago


Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time
Chromatography Expert/Senior Scientist for QC Chromatography

FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Chromatography Expert/Senior Scientist to join our Quality Control (QC) department in Hillerød, Denmark. This role involves working with HPLC and chromatographic analyses in a fast-paced pharmaceutical company.

About the Role:

  • You will be responsible for scientific leadership on Chromatographic assays performed in QC Chromatography, including support in testing, improvements, troubleshooting, and investigations in compliance with cGMP.
  • Laboratory support will be provided if unexpected analytical method trends are observed.
  • You will author technical protocols and reports, such as implementation of new control material for FDBD-owned methods.
  • Responsibilities include 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 is also part of the job.
  • You will handle deviations, invalid assays, laboratory exceptions, CAPAs, and change controls.
  • Ensure compliance with cGMP and serve as a key SME during audits and inspections.
  • Collaborate with the Analytical Development department to transfer new methods for testing in QC laboratories.
  • Drive continuous improvement projects in collaboration with management.

About You:

  • A master's degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or a similar field is required.
  • Prior experience from the pharmaceutical industry is preferred, with knowledge of HPLCs/UPLCs and chromatography analyses.
  • Candidates with a PhD and experience working under cGMP are highly valued.
  • A strong understanding of regulatory requirements and ICH guidelines is necessary.
  • You should possess excellent collaboration skills and a OneQC mindset.
  • The ideal candidate is self-driven, dedicated, thorough, and systematic, with the ability to plan projects and deliverables in a structured way.
  • Fluency in English is required, as it is our corporate language.

What We Offer:

  • A competitive salary of approximately DKK 550,000 - 650,000 per annum, depending on qualifications and experience.
  • The opportunity to work in a dynamic and inspiring environment with a flat organizational structure.
  • A chance to make a difference in the quality control process and contribute to the development of new medicines.
  • Ongoing professional development and training opportunities.
  • A comprehensive benefits package, including health insurance and pension scheme.


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