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Søborg

    Senior Professional, Aseptic Process Drug Product MSAT - Søborg, Danmark - Novo Nordisk A/S

    Novo Nordisk A/S
    Novo Nordisk A/S Søborg, Danmark

    for 1 uge siden

    Novo Nordisk A/S background
    Beskrivelse

    Do you have a passion for production and enjoy working with many stakeholders both internally and externally? Would you like to bridge the gap between our internal sites and our Contract Manufacturing Organisations (CMOs) to ensure consistency across our operations?

    Then look no further: apply today and join our growing Global Contract Manufacturing (GCM) Drug Product Manufacturing Science and Technology (MSAT) department. You might be the Senior Professional Aseptic Process DP MSAT we are looking for.

    The Position

    As Aseptic Process Senior Professional MSAT, you will work closely with our MSAT specialists and other senior professionals in the technology transfer projects of pre-filled syringes, cartridges and vial manufacturing process to our CMO partners who are responsible for manufacturing of our products on behalf of Novo Nordisk. You will be a key player in supporting implementation of new products and processes at our CMO sites, building strong knowledge about NN processes and products at the same time offering technical support and expertise to ensure the smooth running of our external production operations.

    The position has a high degree of independence.

    In this position, you will:

  • Get insight into the production operations and drive solutions whenever production disturbances occur
  • Work closely to our team of MSAT specialists and professionals and internal stakeholders ensuring the implementation of a robust production process at our CMO partners.
  • Gain and hold extensive knowledge of the production including the formulation preparation, filling, inspection, the production equipment, facilities and other processes related to the manufacture
  • Have a strong interaction with Novo Nordisk Manufacturing development areas
  • Make procedural or process suggestions for achieving team goals; providing necessary competences and help to remove obstacles, ensuring the team accomplishes specific results.

    • Several of the CMOs we currently work with are in project phases where extra focus is needed from a set of skilled professionals. The every-day work in GCM can shift in many directions and therefore it is good if you can approach new situations with an open mind. International collaboration is also an integrated part of this position, therefore you will be given the opportunity to travel frequently within Europe and the USA (expected around 25-30 days per year.

    Qualifications

    To be considered for this position, we expect you to:

  • Hold at least a Master's Degree within Pharmacy, Engineering, Chemical Engineering, or any other relevant field
  • Have at least six years of practical experience within the pharmaceutical industry and manufacturing of sterile pharmaceutical drug products (PFS, cartridges, vials, etc)
  • Have some knowledge with Lean 6 Sigma or equivalent, have experience working in technology transfer projects, and/or life cycle management projects within drug product manufacturing operations (ie. Formulation, filling, inspection, etc)
  • Have a solid GMP knowledge
  • Good knowledge of overall practices for drug product manufacturing, aseptic filling process, isolator technology, quality management systems
  • Proficiency in both written and spoken English
  • Have previously worked in an international environment

    • As a person you know how to build trust with stakeholders and you naturally share important and relevant information within your project team and with your colleagues. You have an analytical mind-set with the ability to work in a structured way and an ability to support multiple activities. You enjoy working independently but equally, you like to spare and share knowledge with your peers.

    About the Department

    GCM Drug Product is part of Novo Nordisk's Product Supply organisation. We are responsible for all Novo Nordisk contracts and license manufacturing of semi-finished and finished drug products to global markets. Our main office is located in Søborg, Denmark.

    The primary role of GCM organization is to monitor and control the production handled by external Contract Manufacturing Organisations, ensuring delivery of products from the CMOs to our respective customers. Our CMOs are located in Central Europe, North America and in East Asia. We, in DP MSAT, bear the responsibility for the production, the facility including all equipment and the Quality Management System (QMS) at the CMOs throughout the TT project phase and we work closely with our GCM Operations team providing technical/expertise support during Commercial supply.

    The position is in DP MSAT department, Manufacturing Science and Technology, a team consisting of highly experienced specialists and professionals with strong knowledge and background in pharmaceutical sciences. You will become a part of an international, diverse and well-functioning team that enjoy solving problems in collaboration.

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