- Designing the compatibility studies, including monitoring, trending stability and reporting.
- Preparing documentation such as suitability evaluations, study reports and protocols.
- Preparing external documentation of production materials and primary packaging for submission.
- MSc. or PhD within Pharmaceutical science, Engineering, Chemistry, or other relevant academic area.
- Experience from Pharmaceutical industry, within product development, analysis, or pharmaceutical production.
- Experience/knowledge with stability studies and material knowledge such as polymers.
- Experience within product compatibility and extractables & leachables is considered an advantage.
- Full proficiency in oral and written English.
Senior Product Compatibility Scientist - Gentofte, Danmark - Novo Nordisk A/S
Beskrivelse
Are you looking for an opportunity to combine your knowledge within drug product, analysis, and polymer materials? Are you an innovative and open-minded person with an ability to create a way forward in a complex environment?
If so, you could be our new Senior Scientist in a new SUS & Compatibility Competence Center. Read on to find out more
The position
As a Senior Scientist, you will be part of the Product Compatibility team, and you will work in several different projects, where you will evaluate suitability of new materials, design and document laboratory studies related to product compatibility within production materials (single-use systems and components) and primary packaging across our portfolio of injectable products.
Your responsibilities will include:
Your tasks will be done in a close collaboration with colleagues in the department and you will work cross functionally with various stakeholders across departments and productions sites. Moreover, you will have the opportunity to work in a dynamic and changing environment with a highly engaged and supportive team. We are committed in offering you a creative work environment with great possibilities of developing your professional and personal competences.
Qualifications
To succeed in this position, you have:
As a professional, you thrive on embracing new challenges and navigating complex, dynamic environments. Your personal drive is evident in your proactive approach and desire to make a meaningful impact on the business. Additionally, your role involves working cross-functionally with various stakeholders, necessitating strong communication skills and the ability to openly share ideas and solutions.
About the department
In Injectable Finished Products (IFP) we produce our many high-quality products for diabetes and obesity worldwide. The SUS & Compatibility Competence Center consists of 25 employees divided between 3 teams situated in Bagsværd, Denmark. The main responsibility of the Competence Center is to guide and set direction for the standardisation of SUS and process aids towards all aseptic production sites in Novo Nordisk.
The Biotech & Rare Disease (BRD) Product Compatibility team is working with evaluating and testing the suitability of use of process aids, primary packaging materials for our drug products. It is the responsibility of the team to support with suitability evaluations and supportive laboratory tests for the entire portfolio of injectable drug products in Novo Nordisk from development to drug products on the market.