Validation Specialist, Manufacturing, Science and Technology

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Do you have a background in organic/peptide chemistry and a curious mindset? Have you already worked with Contract Manufacturing Organisations (CMOs) or directly within a CMO? Are you looking for a position with high level of independence and business impact? Then apply today as you might be the Outsourcing Specialist we are looking for to represent our CMOs within Novo Nordisk, and Novo Nordisk within our CMOs! The Position As Validation Specialist, Manufacturing, Science and Technology, you will work closely with CMOs who partner with Novo Nordisk to enable further production of drug substance. You will be the bridge between what the CMOs can do and what Novo Nordisk want to achieve, with a special focus on facility, equipment and Quality Management System (QMS). Several of the CMOs we currently work with are in project phases where extra focus is needed from a set of skilled specialists. After implementation, you will typically not hold day to day oversight with the CMO, but rather be called upon when there is a need for deep knowledge. You will quickly become a visible beacon of knowledge across and beyond a truly global organisation. Some of your main responsibilities include:
  • Writing and reviewing project documentation, validation reports, master batch records, change requests etc.
  • Be the go to person when it comes to technical process and equipment facility
  • Engage in discussions between Novo Nordisk and CMOs to make sure that what the business want is feasible
  • Making sure that 2 QMS are working together, understanding the differences and be able to help close any gaps
  • Giving advice, proposing, and leading through to completion on continuous improvement project.
    • International collaboration is an integrated part of your job, you can expect to be travelling around 25 days per year. Qualifications To be considered for this position, we expect you to:
  • Hold at least a Master’s Degree in Chemistry, Pharmacy, Engineering or any other relevant field
  • Have previous experience with QMS, documentation and working with/within a CMO
  • Possess a strong background in organic chemistry (fermentation, peptides, sidechains…) obtained either within the pharmaceutical industry, food production, or dairy industry
  • Be fluent in English, both written and spoken.
    • As a person, you have excellent communication skills and are good at building trusted relationships with a wide variety of stakeholders. You naturally share important and relevant information. You have a curious mindset and enjoy working independently. Last but not least, you know how to listen and negotiate, but are also able to take a stand when needed. About the Department Global Contract Manufacturing (GCM) is part of Novo Nordisk’s Product Supply organisation. We are responsible for all Novo Nordisk contracts and licence manufacturing of Active Pharmaceutical Ingredients (API’s), intermediates, semi-finished and finished drug products to global markets. Our main office is located in Bagsværd, Denmark. The primary role of GCM is to monitor and control the production handled by external Contract Manufacturing Organisations (CMOs), ensuring delivery of products from the CMOs to our respective customers. Our CMOs are located in Central Europe, North America and in East Asia. The position is in a production support department, Global Contract Manufacturing Support, a team of highly experienced specialists with a well-documented history in pharmaceutical sciences. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Thomas Lindblad, Director, Global Contract Manufacturing Support, drug substance at [email protected] or +45 3075 5179. Deadline 26 September 2023. 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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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 13.7.2023, men kan have været deaktiveret og genaktiveret igen.

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