Senior API Process Supporter

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Hillerød

Are you passionate about biotechnology and pharmaceutical production? Do you have a knack for analysing process data and ensuring smooth technology transfers? If so, you might be our new API Process Supporter! Read more and apply today for a life-changing career. The positionAs a part of the New Products team, you will be responsible for New Product Entry, working closely with approximately 8 dedicated and skilled colleagues. Your primary role as a Process Supporter is to ensure the successful technology and process transfer of new API processes into the existing production facility. Success is achieved when the process is fully implemented and operates smoothly under GMP across multiple batches. Your key responsibilities as an API Process Supporter will include:
  • Coordinating activities with internal and external stakeholders (e.g., process development, equipment, facility, production, automation, Quality Assurance (QA)).

  • Preparing and supporting new product campaigns, ensuring documentation is aligned with current standards, legislation, change requests, and process deviations.

  • Facilitating the transfer of technology, process, and knowledge between development and production teams.

  • Troubleshooting issues related to the daily manufacturing of new products.

  • Initiating problem-solving processes (A3 or similar) for any observed process deviations or production issues.

    • Qualifications To be successful in this role, we imagine that you have:
  • A Master's degree in Bioengineering, Biotechnology, Biochemistry, or a related field.

  • Extensive experience in the production and/or development of pharmaceutical products.

  • Preferably, you have Expertise in mammalian cell cultivation or fermentation, including handling product changes in a GMP-regulated environment.

  • You make data-driven decisions that align with both GMP standards and our strategic goals, with LEAN principles being an integral part of your skill set.

  • Full professional proficiency in Danish and English.

    • As an individual, you possess strong analytical skills, ideally complemented by a solid understanding of cell cultivation processes. You are structured and proactive in your approach, with the ability to work independently. In this role, you will engage with multiple stakeholders across the organization. To succeed, you must remain calm under pressure and make sound decisions in a fast-paced environment where priorities often shift. About the departmentYou will be part of a dynamic business area which produces Active Pharmaceutical Ingredients (API) for patients across the world. The open position is in our API production in Hillerød, working with the upstream process in a mammalian cell culture process. The team is responsible for transferring new products from development to the production facilities in Hillerød, as well as supporting process validation and campaigns of our new products. The team is part of a larger production area with other departments such as production, equipment, maintenance, calibration and IT/Automization.Working at Novo NordiskWe are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk life means many things – from building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Contact For further information, please contact Christiane Wiendahl at +45 30 79 48 62. Deadline 29 September 2024 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.


    Information og data

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

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 17.9.2024, men kan have været deaktiveret og genaktiveret igen.

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