Virology and Bioassay Senior Scientist

4 days ago


Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full time
Job Overview

Fujifilm Diosynth Biotechnologies is a world-leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry.

About the Role

We are seeking an experienced Virology and Bioassay Senior Scientist to join our Quality Control Department at our site in Hillerød. As a key member of our QC Bioassay & Virology team, you will be responsible for ensuring viral safety on products with in vitro Adventitious Virus testing, qPCR MMV testing, and qPCR testing for impurity of in-process samples (IPT) as well as the global release of commercial products (DS/DP).

Main Responsibilities
  • Support testing, improvements, troubleshooting, and investigations in compliance with cGMP.
  • Laboratory support and support to scientist peers if unexpected analytical method trends are observed.
  • Support to the Drug Substance (DS) manufacturing with virology assessment as virology expert for deviation investigation.
  • Author technical protocols and reports for release of working cell banks for DS manufacturing or studies requested by customers.
  • Responsible for product specific qualification in relation to virology testing when transferring new products to our manufacturing facility.
  • Daily QC manager approval of test results for commercial product.
  • Handling deviations, Invalid assays, Laboratory exceptions, CAPAs, and Change Controls.
  • Ensure compliance with cGMP and participate in audits and inspections.
Requirements and Qualifications

The ideal candidate holds a master's degree in a relevant area and has preferably a PhD combined with experience from the pharmaceutical industry. You should have experience working under cGMP and preferably with cell-based assays, cell culture maintenance, qPCR, and virology testing.

A salary of approximately $120,000 per year reflects your expertise and experience in this field. Your annual salary can vary based on your location and other factors.



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