Quality Control Professional, Microbiology

We have an exciting new opportunity for a skilled and experienced Quality Control Professional to join our QC Microbiology team in Hillerød.

In this role, you will be responsible for contributing to key functional, tactical, and operational aspects of the QC Microbiology group. You will actively provide leadership and mentoring as needed to aid in the development of team/peers, self and team projects. You will also provide technical leadership through effective project management, status tracking, presentations, and communication.

Primary Responsibilities

  • Coordinate testing and review of analytical data to support routine testing, test validation and qualification activities
  • Provide microbial assessments and technical/scientific support for our Drug Substance Manufacturing and other departments on the site
  • Provide troubleshooting and support for QC Microbiology, the Environmental Monitoring team and other QC teams to obtain team success
  • Author technical protocols and reports as well as change control requests for ensuring successful execution of qualification and analytical improvement projects
  • Participate effectively in a leadership or membership role for cross-functional teams as a representative of the QC Microbiology laboratory
  • Ensure compliance with cGMP

The QC Microbiology team consists of 10 dedicated employees who enjoys working within the microbiology field. The team performs release testing of DS, DP and also in process testing as part of the control strategy for the DS production, where they monitor Endotoxin and Bioburden on critical in process steps. Furthermore, they also perform testing as part of the utility monitoring (UM testing). The team support the Drug Substance manufacturing area with their microbial knowledge and therefore has close collaboration with various departments in the drug substance manufacturing area. Furthermore, the team also performs particle testing, BacT testing, Microbial ID testing via sequencing and HVLD (CCI testing) for stability samples.

Qualifications / Skills

  • Master or Ph.D degree in Biology, Food Science, Biotechnology or similar, specialised within Microbiology
  • Advanced knowledge and experience in Microbiology
  • Knowledge in GMP or other quality systems
  • Experience with pharmaceutical production or e.g. food industry will be beneficial
  • Excellent technical writing, presentation and communication skills
  • Able to work effectively, independently and within a team framework, across all business areas and levels of the organisation.

Please upload your CV and cover letter in English latest by Sunday 20th of October 2019 . For more information about this role please contact Talent Acquisition Lead Eva Op De Beeck at +45 7221 0860.

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.