Microbiologist to MDEV Microbiology QC

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Gentofte

Are you passionate about analysis development, and are you motivated by ensuring that Novo Nordisk delivers high-quality products to our patients worldwide? We are looking for a skilled, motivated, and energetic microbiologist for a full-time position in Biotech and Rare Disease QC (BRD QC). The position The team, which consists of 7 academics and 5 laboratory technicians, is responsible for validation of microbiological methods for cell banks and products in clinical phases 1 to 3, as well as the following transfer of the analytical methods to our QC laboratories. The methods include the traditional pharmacopeial tests. As a microbiologist in team Clinical Support, you will be responsible for the:
  • Microbiological analytical support to products in clinical phases 1 to 3
  • Validation of microbiological analytical methods – for this specific position mainly endotoxin test
  • Qualification of equipment
  • Preparation of submission documents as well as answers to authority questions
  • Presentation of data and analytical methods during audits and inspections
    • Moreover, you will be expected to contribute to the ongoing optimisation of our existing processes and methods. This also entails being curious about how other teams and departments work, both within and outside Novo Nordisk. Qualifications To succeed in this role:
  • You hold a Master´s Degree in Pharmacy, Engineering, or another relevant field within the natural science., preferably with experience from a QC function in the pharmaceutical industry, but this is not a requirement.
  • You have experience with cGMP, ICH guideline and pharmacopoeia requirements.
  • You have experience and interest of endotoxin test since this will be one of your main responsibilities.
  • You can work in a structured manner, and you deliver to an agreed deadline.
  • You are curious by nature, unabashed by new problems and capable of working both independently and in teams.
  • You have strong communication skills both in spoken and written Danish and English and you find it natural to establish new relationships across teams and departments.
  • You embrace new ideas and changes and are not afraid to take lead and bring new solutions, processes, and improvements forward.
    • About the department QC Microbial Competence Centre, Biotech and Rare Disease QC (BRD QC) is located in Gentofte, and consists of 32 employees, organised in 2 teams, team “Clinical Support” and team “New Methods”. It is within the ‘Clinical Support’ we seek a new colleague. We have a central support function in relation to microbiological analysis of Novo Nordisk Biotech and Rare Disease products during development, as well as on market. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. At Novo Nordisk, it is your skills, your commitment and your ambitions that help us improve the lives of many people. In return, we offer you the opportunity to work with talented colleagues, and we offer you a wide range of opportunities for professional and personal development. Contact If you want to hear more about the position, contact Ann Cherie Zier Grønbech (Director) on +45 30758918 or Marianne U. Gjelstrup on +45 30759348. Deadline The 16th of May 2023. We may conduct interviews before the deadline. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Gentofte.

    Jobbet er oprettet på vores service den 24.4.2023, men kan have været deaktiveret og genaktiveret igen.

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