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Cell Bank Scientist in CMC API Development

Do you want to play a crucial part across all drug development projects by ensuring cell banks for clinical trials? Do you have a quality mind-set and excel when working in an open and dynamic culture focused on team work to accomplish tasks? Then the role as Cell Bank Scientist could be the right position for you.

About the department
You will become a part of the Research and Development organisation in Novo Nordisk. More precisely, you will be part of the department Mammalian Cultivation Development within Chemistry, Manufacturing and Control (CMC) & Active Pharmaceutical Ingredient (API). We are a dedicated team of 25 specialised and experienced employees consisting of scientists and laboratory technicians. As a department we are engaged in cell banking and cultivation process design. We work with new production technology and automated systems to assist us with process development and optimisation.

Lead candidate cell lines are handed over from Research groups to our department. Our task is then to produce and maintain microbial, mammalian and potentially stem cell banks for clinical trials and marketed products under GMP. We do so in close collaboration with the research units as well as our quality assurance organisation, regulatory affairs and Quality Control (QC) laboratories.

The position
As a Cell Bank Scientist, your job will be to produce, store and maintain cell banks under GMP together with other scientists and technicians. You will perform operational work in our laboratory and cell bank facility, but the main part of your job will be handling of documentation. You will ensure that the production of our cell banks, our facility and documents are in compliance with internal and external quality requirements. You will handle change request and actions related to non-conformities from the cell bank production process. Also, you will take part in qualification of equipment and the facility. You will be responsible for maintaining procedures and training material for the area. As we produce and maintain the inoculation material for all Novo Nordisk products, you will be involved in audits and inspections by Health Authorities as well.

We expect you to plan, execute and report assignments independently and in cooperation with the department's staff. In addition, you will be responsible for identifying opportunities for improving processes and compliance.

You hold a M.Sc. within Biochemical Engineering, Chemical Engineering, Pharmacy or similar, and you have experience from the pharmaceutical industry. You may have some years of experience working with microbial fermentation or cultivation of mammalian cells. You have a proven track record within GMP knowledge that enables you to understand what kind of impact changes can have on internal processes and compliance with filed documentation. It is important that you have a strong quality mind-set and are strong at systematic problem solving.

You are goal oriented and take pride in delivering your task at the right time, in the right quality and in the right place so we always reach our targets. You enjoy a working day with very diverse and changing tasks.

On a personal level, you are enthusiastic, committed and self-motivated. You possess excellent cooperation and communication skills, as your ability to interact with colleagues at various organisational levels is the key in achieving success in this position. You bring a can-do attitude and the motivation for taking on new challenges and establishing systems that will bring the facility to the next level.

Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

For further details, please contact Lars H. Christensen on +45 3077 7380 or Susan Aagaard on +45 3075 2712.

25 February 2018.

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