Analytical Validation Chemist within CCI & Physical Methods
Bagsværd, Capital Region of Denmark, DK
Would you like to work with validation of analytical methods for future Diabetes, Obesity, and Haemophilia products? Do you want to join a dynamic department with the responsibility for validation, site support and development of new technologies for Container Closure Integrity (CCI)
If so, you could be our new Analytical Validation Chemist based in Bagsværd. Read on to find out more and apply today and join us for a life changing career!
The position
As the new Analytical Validation Chemist, you will join a team responsible for developing and validating new CCI & Physical methods.
The role involves optimisation of analytical CCI & Physical methods, validation, documentation in internal reports, and providing input to documents for submission to authorities. Additionally, our team is extensively involved in developing new techniques within CCI & Physical methods for the entire Novo Nordisk drug portfolio. As validation responsible you are expected to be involved in that.
Key responsibilities include:
- Solving scientific and technical challenges during method optimisation, validation, and implementation.
- Validation of methods for CCI & Physical methods including dye ingress, break loose glide force, extractable volume and raman.
- Cross functional cooperation with QC laboratories.
- Guiding and reviewing Contract Manufacturing Organizations (CMOs) across the world to support implementation of robust CCI & Physical methods.
- Furthermore, new analytical methods with the purpose of real time release testing will be introduced for CCI, and our new analytical chemists might receive a role in validation and implementation of these technologies.
- Main stakeholders will include colleagues in the department, Quality Assurance (QA), Regulatory Affairs, CMOs and our Quality Control (QC) laboratories.
Qualifications
Your experiences include:
- An academic degree in Pharma, Science, Chemical Engineering or similar, combined with 2+ years working experience within the pharmaceutical manufacturing industry or other highly regulated industries
- Extensive knowledge of analytical chemistry, troubleshooting, optimisation, and validation of analytical methods
- Experience in a laboratory environment, being subject to Good Manufacturing Practise (GMP), preferably with experience with Container Closure Integrity & Physical methods
- Preparing and writing reports for regulatory authorities
- Strong communication skills both in spoken and written English
On a personal level, you thrive in a changing environment and collaborate with colleagues cross functionally, to meet ambitious deadlines. You see yourself as a team player, open-minded and able to use your great communication skills to inspire and motivate colleagues.
About the department
Analytical Science & Methods is a department in Aseptic Manufacturing Science and Technology consisting of about 70 employees in 3 teams. We are the central function for analysis of Novo Nordisk products during development, as well as for marketed products. The department is responsible for the development, validation and implementation of analytical methods before clini-cal phase 3 and the subsequent transfer and ownership of the methods to our QC laboratories across the world. We also support our colleagues globally with analytical knowledge and scientific help as well as drive optimization through innovation. We strive to do all of this in a collaborative environment of joy and curiosity in our department.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of groundbreaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
For further general information, please contact Manager; Sebastian Kubel Dalager on +45 3075 9864.
Deadline
19 June 2025
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. Please upload your CV in English, and to ensure an efficient and fair recruitment process, refrain from adding a photo in 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.