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Novo Nordisk

Analytical Scientist for outsourced materials

Fuldtid

Permanent

Brennum Park 20k, 3400 Hillerød, Danmark

SE PÅ KORT
ID: 2597493
|
Indrykket for 14 dage siden

Do you enjoy analytical tasks within chemistry and would like to work in direct contact with external Contract Manufacturing Organizations (CMOs) supporting analysis of raw materials?

Apply today for a life-changing career as an Analytical Scientist in Analytical Development! You can look forward to an exciting job in an environment where we seek to be the best in class in everything we do.

Enhance your career with Novo Nordisk and apply now!

The Position
As Analytical Scientist for outsourced materials you will support the implementation of analytical methods to our (CMO) for the analysis of raw materials in line with Good Manufacturing Practice (GMP). You will primarily work as a remote support function to the external QC laboratories, with various analytical tasks within method life cycle management.
Your key responsibilities will include:

  • Providing scientific and/or procedural support to CMO laboratories and/or other stakeholders
  • Supporting various projects as with different analytical tasks related to method validation and analytical tasks
  • Assisting technical transfer and implementing analytical methods to/from collaboration partners 
  • Authoring and editing SOPs, reviewing protocols and reports, tech transfer plans and other documentation (No laboratory work expected)
  • Scoping and defining new initiatives with support from the analytical coordinators in the team
  • You will also be involved in the diverse QC assignments we deliver to other parts of Novo Nordisk. This will give you a variety of challenges, and therefore strong collaboration with your colleagues will be essential. You will be part of a team where ideas, problems and solutions are discussed in an open and positive atmosphere.

    You will work primary from Hillerød, and some international traveling will be expected.

    Qualifications 

    To be successful in this role we imagine that you have:

  • A Master´s Degree in Chemistry, Pharmacy, Engineering, or another relevant field within the natural science coupled with a solid practical knowledge within analytical method validation
  • Strong practical and theoretical background within QC analytical methods will be required, e.g., HPLC, GC, KF for raw materials, starting materials and/or intermediates
  • Experience with GMP, ICH guidelines, EP/USP and regulatory requirements 
  • Worked in a GMP environment as for example a QC laboratory or support department having a broad understanding of analytical chemistry
  • Experience as a project manager within a regulated industry, preferably from pharma
  • Excellent communication skills in both written and spoken English
  • It will be an advantage if you have experience in working with CMOs, including method validation, verification, and transfer as well as qualification of equipment in a GMP regulated environment at CMOs.

    On a personal level, you are a team-player with a high level of interpersonal sensitivity. You are structured, proactive, enthusiastic, and comfortable in taking the initiative and lead. You thrive in a multicultural and ever-changing environment with a high level of complexity.

    You are naturally good at communicating with all types of stakeholders both verbally and in writing. You are motived by the opportunity of getting a large network in and across our area. We expect that you can set the direction and drive performance, ensuring quality and speed while being pragmatic. Balancing conflicting inputs by respecting and including others’ opinions viewpoints is essential. 

    About the Department
    You will join our analytical support CMO Team in Material Manufacturing Development – Department for Analytical Development in Product Supply Sourcing Operations. We consist of 50 employees, located in Hillerød. We are responsible for development and implementation of complex materials at all Novo Nordisk sites.

    We cooperate with a variety of functions, including external CMO’s and internal Warehouses, Quality Control and Strategy and business development as well as Novo Nordisk sites all over the world.

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