Senior Purification Scientist

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Gentofte

Are you ready to make a difference for people living with haemophilia and other rare diseases? Do you want to work with transfer of new API processes from development to commercial launch in Biotech & Rare Disease (BRD)? Thus, being a vital part in securing new treatments to chronic patients worldwide. BRD’s portfolio is expanding, and we are therefore looking for an additional senior purification scientist at our Novo Nordisk site in Gentofte to support the antibody API production at site Hillerød. The position As a senior purification scientist in our New Product Entry team you will be involved in one or more projects either in phase 3 or in a transfer phase from development to process validation (PV) before commercial launch. You will work closely with API coordinator/s who represent our department, BRD API Manufacturing Development, in the project core teams and coordinate the relevant deliveries across the organization. Your major tasks will include:
  • Transfer of process knowledge and process responsibility from development to BRD prior to PV (before commercial launch).
  • Preparing API processes for PV (e.g., process characterisation activities, establishing PV acceptance criteria etc.).
  • Creating and keeping central process and control documents as master formulas, in-process control documents and drug substance quality specifications updated.
  • Setting up drug substance stability strategy for new drug application (NDA) submission and on-going stability.
  • Suitability evaluation of process aids and single use equipment used in production.
  • Support to solve and prevent issues in the API production at site Hillerød.  
  • Collaboration with a wide range of stakeholders across Novo Nordisk e.g., production departments, Quality Assurance, development, Regulatory Affairs, analytical departments and project groups across development and BRD.

  • Qualifications To succeed in this position, you have:
  • An academic degree within a scientific field such as biotechnology, chemistry, engineering or similar.
  • +5 years of experience working with protein purification. Experience in pharmaceutical production and experience with LEAN methods.
  • Experience with project management or/and stakeholder management.
  • Full professional proficiency in oral and written English.
  • Strong communication and collaboration skills are of key importance to ensure efficient distribution of tasks and alignment across the team, the department and within BRD. As a person, you are outgoing and self-driven. You thrive in an environment where you get to throw yourself in at the deep end, always seizing an opportunity for personal and professional development.  BRD is expanding rapidly, and the project plans are ambitious, which means that you should be able to enjoy the fast pace and be pragmatic to find the correct level in your professional tasks to live up to requirements while also supporting the business needs.
    About BRD Manufacturing Development
    BRD Manufacturing Development & Quality Control has its base in Denmark. What some companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 870 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio. Our area also includes the Quality Control unit for all BRD’s products. Together we drive change by always looking for improvements within our processes and in the way we work to make our products reach as many patients as possible.

    Working at BRD, Novo Nordisk
    BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2500 colleagues committed to driving change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?

    Contact  If you have any questions about the position, please do not hesitate to contact Associate Manager Camilla Christensen at [email protected].   Deadline  3 December 2023. We will review applications and conduct interviews on an ongoing basis, so you are encouraged to apply as soon as possible.
    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 to 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".

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    Jobbet er oprettet på vores service den 7.11.2023, men kan have været deaktiveret og genaktiveret igen.

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