Reference Material Professional
Novo Nordisk US
Do you have strong analytical skills and project management experience? Are you passionate about making a difference in the lives of patients by implementing new drugs? Join our dynamic and highly competent Reference Material team as a Reference Material Professional.
As a Reference Material Professional, you will be responsible for driving the process of maintaining and establishing reference materials for all products in the Biotech and Rare disease (BRD) product portfolio. Together with 4 colleagues you will be responsible for coordinating the tasks related to reference materials.
Your primary tasks will be:
- to coordinate the production and analysis of the reference materials
- to prepare the supporting documentation
- to implement and maintain the reference materials.
- to support the internal users of reference materials at Novo Nordisk
Furthermore, as a part of your job, you will:
- conduct life cycle management activities for all BRD reference materials throughout the lifetime of the product.
- ensure performance, evaluation and documentation of stability studies on all BRD reference materials.
- prepare regulatory documentation for various authorities and answer questions to the documentation.
You will be a part of a small group that is well structured and pursues solid results through good collaboration. You will be working broadly across the organization, including interactions with relevant analytical laboratories, scientists, project managers, regulatory affairs, statisticians and QA. You will be part of a Reference Material network across Novo Nordisk. You will join a harmonious team and department with competent, caring, and positive colleagues.
To be successful in this role, you have:
- A relevant academic degree, preferably a master’s degree, within Pharmacy, Chemistry, Engineering or a similar field.
- Solid experience in successfully managing and executing projects in pharmaceutical industry.
- Relevant experience from working with reference materials, analytical development, production, or QC.
- Experience from working with product specifications, analytical methods, production and/or regulatory documentation in the pharmaceutical industry is an advantage.
- Full professional proficiency in English.
On a personal level, you enjoy working on long-term projects. You take responsibility and you work in an organized way until the projects are fully implemented. You are naturally good at communicating with all types of stakeholders both verbally and in writing. This helps you to keep all your stakeholders aligned, informed and engaged.
About the department
Your new department, Analytical Manufacturing Development is part of Biotech and Rare Disease (BRD). We develop and validate analytical methods for production and QC.
We are approx. 65 employees located in Gentofte. We have innovation in focus, and we implement new technology continuously.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
In BRD we are not only supplying all Novo Nordisk products for rare diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone.
For further information please contact Manager, Karen Kirketerp at KKIP@novonordisk.com
4 March 2024.
Applications will be reviewed continuously. However, interviews will be conducted after the deadline.
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. To ensure an efficient and fair recruitment process, please 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.