Do you dream about having a true impact on patients worldwide? Are you ready to bring your skills and knowledge and take the next big step on your career path? Would you like to be responsible for the technical transfer of new processes to our existing facility?
Then you might be our new Downstream Process Scientist for our Active Pharmaceutical Ingredients (API) production in Hillerød. Apply today for a life-changing career!
The Position
As a Downstream Process Scientist, you will be a part of the New Products team responsible for New Product Entry which currently consists of 8 highly dedicated and skilled colleagues.
The primary responsibility of this role is to oversee the technology and process transfer of new API processes into an established production facility, working collaboratively with colleagues from production. Success is achieved when the process is fully implemented and operates seamlessly under GMP standards across multiple batches.
This position is centred on processes such as mammalian cultivation, recovery, and purification, with a particular emphasis on downstream activities. Key tasks include gaining an in-depth understanding of the new processes, transferring knowledge from development teams, and implementing these processes within the current facility. Driving necessary process adjustments through close collaboration with various key functions, such as equipment experts, production process support, and automation teams, is essential part of the working day.
The role also encompasses responsibilities such as drafting procedures, process documentation, protocols, validation documents, and change requests. Leading up to the initial production campaigns, ensuring thorough training and knowledge transfer for operators and process support staff is critical. Additionally, this position plays a pivotal role in supporting ongoing production efforts.
Your main focus will be on:
• Coordination of activities with internal and external stakeholders (process development, equipment, facility, production, automation and QA).
• Being responsible for preparing and supporting campaigns for new products, including required documentation in accordance with the current standards and legislations, change requests and process deviations.
• Ensuring technology, process and knowledge transfer between development and production.
• Troubleshooting related to the daily manufacturing of new products.
• Initiating problem solving (A3 or similar) for observed process deviations or other issues in the production of the new products.
Qualifications
To succeed in this role, you have:
• A master’s degree or a PhD in bioengineering, biotechnology, biochemistry or similar field.
• A minimum of 4 years of experience in a production and/or development of pharmaceutical products.
• Experience in downstream processing (chromatography, filtrations, virus filtration, UF/DF) with changing products under Good Manufacturing Practice (GMP), which is considered a plus.
• Full professional proficiency in written and spoken English, while being proficient in Danish is considered a plus.
As a person, you have great stakeholder management and communication skills, that enable you to communicate with multiple stakeholders across the organization. Having a solid knowledge of cell cultivation processes and LEAN is crucial to succeed in this role.
A keen eye for detail, strong analytical skills to interpret process data from development and production, a solid understanding of production processes, a robust GMP mindset are key attributes sought for this role.
A structured and proactive approach to work, the ability to operate independently and as a team player, with a focus on making data-driven decisions that align with GMP requirements while supporting strategic objectives are qualities we like to foster in our team. We will welcome a colleague who is able to keep a cool head and make decisions in a busy work environment where the agenda changes frequently.
About the Department
You will be part of a dynamic business area which produces Active Pharmaceutical Ingredients (API) for patients across the world.
The open position is in our API production in Hillerød, working with the downstream process in a mammalian cell culture process. The team is responsible for transferring new products from development to the production facilities in Hillerød, as well as supporting process validation and campaigns of our new products. The team is part of a larger production area with other departments such as production, equipment, maintenance, calibration and IT/Automation.
About Site Hillerød
Site Hillerød is an innovative and fast-growing production site. With over 4,000 talented employees, we work together to drive change for people living with serious chronic diseases. The site is located in beautiful natural surroundings, and we offer a diverse array of career paths at all educational levels. Join our vibrant community at Site Hillerød and ramp up your career while we ramp up our production! Get to know us better - visit our Site Hillerød career page Novo Nordisk Hillerød.
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 Senior Manager Christiane Wiendahl at +45 30794862.
Deadline
23 March 2025.
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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