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Novo Nordisk

Downstream Process Supporter

Fuldtid

Permanent

Brennum Park 20k, 3400 Hillerød, Danmark

SE PÅ KORT
ID: 2737742
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Indrykket for 84 dage siden

Are you passionate about process optimisation? Do you want to play a key role in bringing new pharmaceutical products to life? We are looking for a process supporter being responsible for the technical transfer of new processes to our existing facility.

If this sounds like you, read on and apply today for a life-changing career! Read more and apply today for a life-changing career.

The position

As 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. The processes include mammalian cultivation, recovery and purification, where this position focuses on the downstream/purification part. 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 department

    You 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.

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