Quality Control specialist for Bioassay and Virology

QC Bioassay & Virology – your new team

We are a team of 12 dedicated technicians and scientists who enjoy working within the field of both Bioassay and Virology. We support the biologics Drug Substance production as well as the release of commercial products (DS/DP) for our clients, where we perform test on Drug Substance (DS), Drug Product (DP), stability and on in-process samples. We perform qualification of reagents and handle invalid assay assessments, deviations, CAPAs and Change Control.

We are part of the Quality Control department with approximately 90 employees divided into several teams including five testing teams; QC Microbiology, QC Bioassay and Virology, QC raw materials, QC Chemistry and QC Chromatography.

Your primary tasks are:

  • Coordination of testing, review and approval of analytical data to support routine testing, test validation and qualification activities
  • You will be scientific responsible (SME) on assays performed in Bioassay and Virology with regard to testing, improvements, troubleshooting and investigations in compliance with cGMP
  • Writing invalid assay reports, handling deviations, CAPAs and change controls
  • Author technical protocols and reports as well as change control requests for ensuring successful execution of qualification and analytical improvement projects
  • Ensure compliance with cGMP
  • Support to the laboratory if unexpected analytical method trend is observed

If you can see yourself in this role, then we can offer an exciting and challenging job in a company where there is a very exciting future with many partners and products, possibility for personal development and in a team of competent and engaged employees full of humour.

Qualifications

  • Have a scientific background in Virology/Molecular Biology with preferably more than 3 years of experience from the pharmaceutical industry or other
  • Have experience in handling cells
  • Knowledge in GMP or other quality systems
  • Being agile
  • Have a welcoming and “can-do” attitude
  • Capable of being able to absorb and utilize new knowledge quickly
  • Able to work effectively, independently and within a team framework, and have strong collaboration skills
  • Excellent technical writing, presentation and communication skills
  • Excellent oral and written communication skills in Danish and English

Education

  • Preferably Master or Ph.D degree in Virology/Molecular Biology, Food Science, Biotechnology or similar

Please upload your CV and cover letter latest by 31st of October 2019.

Apply

FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and Manufacturing Organisation (CDMO) with over 25 years’ experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.

As part of FUJIFILM Diosynth Biotechnologies , you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, you family and your professional growth.

FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes individual responsibility, allowing you to grow and progress. We support our employees with programs that motivate and educate, promoting a healthy work-life balance that ultimately increases personal well-being and employee satisfaction.