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Analytical Specialist

2 weeks ago

Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

Are you ready for a role as Analytical Specialist within analytical methods used for testing of peptide/protein-based injectable drug products in Novo Nordisk?

Are you eager to use your solid experience and competencies within analytical testing techniques such as HPLC, UHPLC, AAS, Raman, ICP and Container Closure Integrity testing to guide and support your colleagues in the department and in Novo Nordisk QC laboratories globally?

Are you detail-oriented, positive, energetic, and flexible? Then you may be our new colleague to join the Analytical Science & Methods department. Read more and apply now

The position

The department is growing, and we are therefore looking for an Analytical Specialist to start in a newly created position. As our new Analytical Specialist, you will ensure that our analytical methods are scientifically sound and fit for purpose, as well as ensure that the methods are in compliance with internal and external requirements. Moreover, you will ensure that we provide competent input for method-related questions and complex problem solving in our own laboratory, in Novo Nordisk QC laboratories globally as well as Contract Manufacturing Organisations (CMOs). You will do this in close cooperation with our current analytical specialists.

The job is placed in Method Support & Transfer which is a unit in the department consisting of approx. 20 people organised in two teams, Analytical Method Support and Analytical Method Transfer, plus two analytical specialists and a quality coordinator. Like them, you will report to the Senior Manager of Method Support & Transfer.

Key responsibilities:

  • Overall responsible for the quality of analytical procedures for new injectable drug products to be implemented in Novo Nordisk QC laboratories.
  • Overall responsible for supporting chemical analysis of injectable drug products, both internally in the department and globally in QC laboratories as well as CMOs by assisting with method-related questions and complex problem solving.
  • Overall responsible for documentation of analytical methods on marketed injectable drug products - and compliance to pharmacopoeias and external requirements.
  • Overall responsible for scientific support and evaluation for various optimization, automatization, and development projects in our area.

As we work under GMP requirements, Change Requests, SOP updates, deviations etc. are a natural part of the job for the chemists in the unit, and they may need your guidance on this.

Your main stakeholders will be colleagues in the department and area, QC laboratories across the world, CMC, API, QA and Regulatory Affairs. A few days of travel per year might be expected.

The analytical methods are primarily UPLC/HPLC-methods, but also include Raman, pH measurement, AAS, Freezing point depression, and different container closure integrity methods.

Qualifications

We are seeking a candidate with several years of experience and imagine that a successful candidate will have:

  • A Ph.D. in a relevant area within pharmacy, life sciences, chemical engineering or similar.
  • Extensive experience within analytical chemistry, troubleshooting, optimisation, and possibly validation of analytical methods.
  • Extensive experience from a GMP-regulated laboratory.
  • Extensive experience as an analytical chemist working with techniques such as HPLC, UHPLC, AAS, Raman, pH measurements, ICP and familiar with Container Closure Integrity testing and chemometric methods.
  • A good overview of the regulatory process in connection with submission of new products.

On a personal level, you are detail-oriented, proactive, and enjoy providing support to and guide/mentor colleagues. You have excellent communication skills, and you are fluent in English. You thrive in a dynamic environment with ambitious deadlines and maintain a positive mindset in all situations. Additionally, we expect you to stay highly motivated, and positively impact your cooperation with the internal and external colleagues.

About the department

Analytical Science & Methods is a department in Aseptic Manufacturing Science and Technology (AMSAT) and consists of approx. 70 employees organised in 5 teams. We have a central support function in relation to chemical analysis of Novo Nordisk injectable finished products under development, as well as our marketed products. We are responsible for analytical testing techniques such as chromatography – HPLC/UHPLC, Container Closure Integrity testing – Dye Ingress/Helium Leak Detection, pH measurement etc.

The department is responsible for validation of analytical methods for late-phase development and marketed products and thereafter for the following transfer of the analytical methods to our QC laboratories and CMOs across the world. We also support our colleagues globally with analytical knowledge and scientific help as well as drive optimisation of the analytical methods. Furthermore, the department is on a journey involving scouting, testing, and implementing fast analytical techniques that can reduce the lead time for analysis with the ambitious long-term goal of real time release testing of injectable finished products.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That's why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 60,000 employees. Together, we go further. Together, we're life changing.

Contact

Deadline

5th January 2025

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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