Formulation Professional

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Søborg

Do you have in depth experience within formulation of drug product, and a service mindset to support global manufacturing of Injectable Finished Product? We are looking for a Formulation Professional, who can join our team of Formulation and Filtration experts, to support Injectable Finished Product (IFP) sites globally, with a variety of drug product manufacturing tasks. Apply now and join us! The position In this position we are looking for a professional who has experience within formulation and /or large-scale manufacturing experience. You will be responsible for supplying a broad range of stakeholders, with detailed knowledge of the products and process, as well as using critical thinking in order to most efficiently provide support in production impacting cases. We also support innovative manufacturing development projects with new technology as process experts. As product and process owners, we also play a key role in the strategic launch of our products globally. By aiding in submissions and global product launches. To help Novo Nordisk to ensure stable delivery of our products to our patients, you will be answering questions from affiliates, related to submission of our products and writing and reviewing regulatory documentation related to our formulation process. You will give input to critical production deviations from IFP, local manufacturing and contract manufacturing sites, additionally to some specific tasks such as:
  • Providing product information to regulatory affairs.
  • Supporting IFP sites during routine inspections from health authorities.
  • Maintaining and updating product & process specific documents.
  • Assisting in upscaling or transferring of products to production sites.
  • Review of validation and registration documents.
  • Assisting and driving optimisation projects to improve IFP formulation activities.
  • Handling and reviewing product data
    • Alongside this, you will be expected to display flexibility and teamwork skills, as we often operate with changing priorities and short deadlines to best serve the production sites. The team needs to be dynamic to support each other as best we can share workload and to best support our stakeholders effectively. Qualifications To succeed in this role, we expect you to have:
  • A Bachelor's Degree or higher academic education background within science, engineering, pharmacy or similar.
  • 3+ years’ experience working within a GMP environment, preferably in drug product manufacturing.
  • Formulation knowledge and solid experience with sterile filtration & validation.
  • Excellent communication skills, with experience of working effectively with stakeholders.
  • Fluency in spoken and written English.
    • On a personal level it is key you have excellent communication skills as you will be working cross functionally building relations with stakeholders at all levels. This collaboration will be best served with a LEAN mindset and systematic approaches to problem solving. The position can often require managing several urgent tasks simultaneously with each their own broad group of stakeholders, therefore you are expected to have strong organisation skills and display a reliable overview of your own deadlines. A structured and pragmatic approach to tasks is required. Our organisation is expanding rapidly, and we encourage bold engagement and a willingness to work smarter, not harder. About the Department Our department, Site Support and Improvements, is part of Manufacturing Development, which is a part of the Injectables Finished Products organisation. It is based at Søborg, Denmark. In Manufacturing Development, we have the expert knowledge of our products and the processes which is needed to support our production sites. In our team, we take ownership for the product quality of each drug product manufactured in IFP, based on our intimate product knowledge and a network of experience of the formulation processes globally. You will be working in a team of 10 professionals of Scientists and Regulatory writers. Whilst working independently in this position, you will have support of highly skilled colleagues within formulation and filtration, as well as support from across the entire department in related processes which impact product quality. 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. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information you are welcome to contact Anneka Hastings (Senior Associate Manager) on +45-30798503. Deadline 26 November 2023. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. 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.


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 14.7.2023, men kan have været deaktiveret og genaktiveret igen.

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    • Øvrige
    • Søborg
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