Senior Reference Material Professional

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Gentofte

. Are you ready to apply your project management experience and analytical skills in an exciting organization, where you will get challenged and expand your capabilities to the fullest? Do you want to take part in the implementation of new drugs and make a difference in our vision to change the life of patients with rare diseases? Then you might be the new colleague we are looking for to join our team as Reference Material (RM) Coordinator. Apply today and join us! The position As a RM Coordinator, you will play a key role in managing the reference materials of all current and future products in the Biotech and Rare Disease (BRD) product portfolio. Together with 4 other RM coordinators you will be responsible for coordinating all tasks related to reference materials, such as implementation and maintenance. This can include production and establishment of reference materials, setting specifications, stability studies etc. You will be a part of a small group that is well structured and pursues solid results through good collaboration. You will work closely with RM Coordinators in CMC Development on the transfer of reference materials from CMC to Product Supply. Furthermore, as a part of your job, you will:
  • Support the internal users of reference materials at Novo Nordisk laboratories and productions sites.
  • Be involved in answering questions and preparing regulatory documentation for various authorities.
    • Your daily work will have you working broadly across the organisation, including interactions with relevant product scientists, product coordinators and statisticians in BRD. And you will also interact with several stakeholders in production, CMC, regulatory affairs, QA and QC. Finally, you will join a harmonious team and department with competent, caring, and positive colleagues. We have a strong foundation of employees with high seniority mixed with newcomers. Qualifications You will be a great asset to our team because 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 in implementing new reference materials and processes. You should enjoy taking responsibility, work in an organised way, be visible and finalise projects until 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. You are motivated by the opportunity of getting a large network across the organisation. About the department You will become a part of Biotech and Rare Disease (BRD) Analytical Manufacturing Development. We validate and optimise analytical methods for new products within haemophilia and other rare diseases based on new technologies. We develop analytical methods to reduce lead time, or to increase yield or capacity in production facilities and QC laboratories. We have innovation in focus, and we implement new technology continuously. Working with various kinds of tasks and professional challenges, we use our professional skills combined with systematic problem solving. The department also covers preparing regulatory documents and coordination related to analytical development and reference materials. Working at BRD, Novo Nordisk BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. 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. We are app. 2500 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we are also striving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact For further information, please call Senior Manager, Taus Laurent Meincke +45 30 79 96 84. Deadline 10 September 2023. But please apply as soon as possible as we will be conducting interviews on an ongoing basis. 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.


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    Jobbet er oprettet på vores service den 25.7.2023, men kan have været deaktiveret og genaktiveret igen.

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