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Senior Research Scientist responsible for cGMP Cell Bank facility

Can you build on processes and implement them in GMP cell banking format?

As Senior Research Scientist at Chr. Hansen – you will be part of the newly established Microbiome Center within Microbiome & Human Health Innovation.

The Microbiome Center is responsible for developing manufacturing processes and establishing cell banks for GMP production of therapeutic bacteria, particularly strict anaerobes, to be used in clinical trials. Together with the team of scientists and technicians, you will work both with Chr.Hansen’s proprietary strains as well as those of external partners to develop robust, high yield and GMP compliant procedures. Together with the team you will build on the processes that are developed for the strains, and implement them in GMP cell banking format. You will also be responsible for the cGMP Cell Bank facility (Seed Lab), which produces GMP cell banks, along with management of outsourced GMP manufacturing  activities.

The Senior Research Scientist reports to Director, Microbiome Center.

Your main tasks are to:

  • Assure GMP compliance of the procedures of the Seed Lab, e.g. assurance of raw material quality, media preparation, cell bank production, QC testing and documentation for clinical trial applications
  • Be owner of validation plans, activities and documentation, and assure that equipment and facility are in compliance
  • Assure adherence to Chr. Hansen’s requirements for traceability, safety and purity of strains for clinical trials
  • Interact with regulatory authorities, external partners and Chr. Hansen QA in connection with inspections
  • Expand capacity of the facility in alignment with commercial needs
  • Build competencies together with other relevant parts of the Chr. Hansen organization by networking with experts and stakeholders
  • Be responsible for planning and following up on tasks for staff (1 -2 technicians) dedicated to the Seed Lab

Ideally, you hold a M.Sc. or Ph.D. within microbiology, preferably having knowledge within strict anaerobe. You have at least 5 years of experience with GMP from production. It is also expected that you have experience with producing and documenting cell banks and are familiar with fermentation techniques (upstream). Furthermore, you know about creating and maintaining quality systems, qualification of clean rooms, equipment, and utilities. 

You are a person who has the ability to work in a dynamic environment and the motivation for taking on new challenges and is able to establish systems that will bring the facility to the next level. As a person, you have a high level of drive, ambition, and passion. You take initiative, are persistent, pay a high level of attention to details, and you are goal-oriented with a scientific mindset. You can manage projects and communicate clearly towards your stakeholders.  Finally, you are quality driven, open-minded, robust, able to stand firm, and you like to have fun.

Chr. Hansen offers you a position in a highly dynamic and successful company with a competitive remuneration package. This will allow you to operate at the interface of a breakthrough science area and a high profile business landscape. You will join an international team of motivated colleagues.

Travelling: 5-10 days a year

Domicile: Hørsholm, Denmark (Headquarter)

For more details about the job or the company, please contact Senior Consult, Jannie Jensen, at  Unique Human Capital on M: +45 29 72 78 86. All applications must be submitted in English and are treated confidentially.

 

Chr. Hansen is a global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. The products include cultures, enzymes, probiotics and natural colors, and all solutions are based on strong research and development competencies coupled with significant technology investments. Revenue in the 2015/16 financial year was EUR 949 million. The company has more than 3,000 dedicated employees in 30 countries and main production facilities in Denmark, France, USA and Germany. Chr. Hansen was founded in 1874 and is listed on Nasdaq Copenhagen.

See more www.chr-hansen.com

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