Method Development Advisor

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Hillerød

Are you passionate about method development and improvement? Are you the type of person who enjoys driving changes and setting standards? If the answer is yes, then we might have the perfect role for you within our Device Quality Frame Specification and Method team in Device Manufacturing Development. We are looking for someone to help us to ensure that Novo Nordisk delivers high-quality products to patients worldwide. So what’s stopping you, make a change and apply today. You could be the one who will set the framework for testing of prefilled/durable and digital combination products! The position
Our new Method Development Advisor is an exciting position because you will be pioneering the way, establishing quality baselines and setting up new frameworks. Your main responsibilities will be to develop, validate, and optimise test methods for device functionality and performance testing within the following purposes:
  • Quality Control test methods for release, and activities such as method transfer and comparability studies between sites and external suppliers.
  • Stability test methods used for regulatory submissions.
  • Test methods to support Process Validation (Process Qualification from production lines globally).
  • Design Verification Testing for new device variants and for design changes.
  • You will work with both new products under development and variants of marketed products. You will also actively contribute and drive the ongoing optimisation of our existing processes by introducing automated processes and new state-of-the-art methods. Finally, you will prepare input for the submission documentation of new products and be part of responses to authorities in close collaboration with Device Research & Development and Regulatory Affairs. There will also be opportunities to develop within Quality Specifications for devices, which determine if a product has the required high quality to be released to patients. This position requires close collaboration with a wide range of internal and external stakeholders, global production sites and affiliates. So you can look forward to building relationships with many people at global and as well as having the scope to make a high impact on the quality of our end products. If all this isn’t enough you will also get the opportunity to undertake international travel a few times a year, to some of our sites in Brazil, US, China, or France. Qualifications
    For this role, we look forward to connecting with candidates who:
  • Hold a master’s degree or engineering degree within natural science such as Pharmacy, Biotechnology, Veterinary or any other relevant field.
  • Can bring in their experience with method development and validation in the pharmaceutical industry, and Good Manufacturing Practice (GMP).
  • Have a previous experience within injectable devices or Drug Device Combination products (DDC).
  • Can embrace new ideas and changes and is not afraid to take the lead by bringing forward new solutions, processes, and improvements.
  • Be fluent in English both written and spoken.
  • It would be considered as an advantage if you have a previous experience in quality and/or production. Who are you as a person? While we do not believe that there is such thing as the ideal candidate, we think you will thrive in this role if you work in a structured manner, and you are able to deliver to an agreed deadline. The nature of the work that we do requires that you are curious by nature, able to perform systematic problem solving and capable of working both independently and in teams. You are confident when you make decisions and can find the right balance between quality demands, authority demands and the business needs. About the department
    You will be part of Device Manufacturing Development (DMD) Product Control & Global Support, where we support device development from the early R&D development stages into production for clinical trials and eventually into production to market. We are a team with employees that are both Danish and international, coming from various educational, as well as cultural backgrounds. We complement one another’s knowledge and skills, always seeking to help, support and spar when someone needs it. At work we try to keep a light and informal tone, so if you can bring a dose of healthy sense of humour along, then you will fit right into the team. 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 please contact Charlotte Hunding at +4530799197. Deadline
    5 February 2023. Please note that applications will be reviewed, and interviews will be scheduled 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.


    Information og data

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

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 13.1.2023, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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