Technical product supporter for New Product Entry

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Gentofte

Are you motivated by the pulse in a production department? Do you want to be part of a strong team with high professionalism and challenging processes? And do you want to be a part of the project group implementing and validation our new Isolator filling line in Biotech and Rare Disease production in Gentofte? Then it could be You we are looking for in our team. About the department In Novo Nordisk Biotech and Rare Deceases (BRD) we focus on helping our patients who suffer from chronical diseases like haemophilia and other rare deceases. Our department is responsible for Isolator filling & freeze drying of products that changes the daily lives of our patients around the world. We are approximately 140 colleagues and are currently implementing 2 new aseptic isolator filling line. The department is responsible for NPE (New Product Entry) which are responsible for the product transfer of new products from CMC to our aseptic Filling site in Gentofte. The department is characterized by highly engaged, professional colleagues, an open, respectful, and involving atmosphere and focus on individual, organizational and process development. The department is growing, and we are thus looking for an additional Technician to support in transfer of product to our new isolator filling lines currently under validation and construction at the manufacture. The position As technical product support in New Product Entry, you will be a part of a highly skilled product transfer team responsible for transferring and implementing new Biotech products in our aseptic filling facilities in Gentofte. The team is involved in the production of products from phase 3 until approval for the marked. The job includes;
  • Preparation for product transfer in collaboration with the production department, securing material and equipment ready for use for the PC, PV, or clinical batch execution.
  • Preparation of production SOPs ready for product transfer and batch execution
  • Update of part lists, sampling plans and specifications in LIMS.
  • Responsible for sample handling including Forecast to QC labs, LIMS handling and transportation of samples to QC laboratory´s timely
  • Sample handling during the production
  • Coordination of activities
  • Preparation of Protocols, reports, and other documents according to experience and training
  • Review of documents in the team
    • In the position you will be collaborating closely internally in the department as well as with other production departments and Manufacturing Development. Qualifications To succeed in this role, you have;
  • A bachelor’s degree within natural science, which could be pharmacologist, laboratory technician or other relevant areas.
  • You have a quality mindset
  • You are a team player
  • Positive and “can do” mindset
  • Experience in working in a highly regulated environment according to cGMP (good manufacturing practice)
  • Full professional proficiency in English
  • Proactive and solution-oriented mindset when it comes to solving your tasks
  • Preferably experience in working with new product entry in a production facility and experience from aseptic production
    • Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication, and ambition to help people with diabetes and change their lives. By working with us, you will have the opportunity to do the same in a global business environment. In exchange, we offer you a chance to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information about the position, please contact Marianne Schaumann at +45 3079 4945 or Associate Manager, Kim Bech Poulsen at +45 3079 0613. Deadline March 5th, 2023. Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. You can apply in both Danish and English. 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 15.2.2023, men kan have været deaktiveret og genaktiveret igen.

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    • Gentofte
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