Pilot Scientist with Production Responsibility at CMOs

Are you passionate about pilot production, fermentation and recovery of drug substances? Do you want to be the link between research and production and be responsible for productions at our CMO´s? Are you interested in being part of a team that fosters a strong team spirit and values collaboration?

Then you could be our new colleague as Pilot Scientist with production pesponsibility at CMOs. Apply today!

Get introduced to CMC API Pilots and meet our employees by visiting our  career site.

The position 
As a Pilot Scientist within Cultivation Pilot Plants, your primary responsibility will be responsible for production campaigns at our CMO´s. This will involve overall GMP and production input to the project by participation in project teams internally. You will be collaboration with the CMO of Master batch record, conduct batch review, change requests and deviation handling, as well as troubleshooting to ensure successful completion of campaigns. 

Your responsibilities will include:

• Preparing and the release of product. 
• Preparing campaign reports. 
• Scientific collaboration with the process development laboratories in all stages of the production campaigns and process evaluation. 

Given our structured approach with LEAN, we expect you to be motivated and enthusiastic about identifying and implementing improvement projects at Novo Nordisk. 

Qualifications 
To thrive in this role, you have: 

• Master’s degree or PhD in fields such as chemical engineering or similar.
• Several years of experience in protein purification or drying, either in a pilot or production environment complemented by solid understanding of fermentation and/or recovery process operations, in one or more of the areas of fermentation, filtration, chromatography and the like.
• Preferably you have experience working with CMO´s.
• Strong compliance mindset with focus on product quality for the benefit of our patients. 
• Experience working in accordance with GMP guidelines complemented by a sys-tematic approach to solving problems and performing your tasks, particularly in what concerns managing deviations.

To be successful in this role, it is important that you have excellent collaboration and communication skills, building strong relations with relevant stakeholders with diverse scientific backgrounds. You can navigate in the discussions due to potential differences in QMS at CMO and Novo Nordisk. You should be proactive in identifying tasks and issues that need to be addressed and capable of solving them independently. 

It is expected that you can handle several tasks simultaneously while maintaining a clear overview, even in high-pressure situations. You are highly committed to drive tasks forward and ensure that they are completed within the specified deadlines. 

As an individual, you have a positive attitude, are a team player, and can motivate your colleagues. You thrive in fastpaced environment, where two days are not alike.

About the department 
As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a “can do” mind-set. The primary responsibility of Cultivation Pilot Plants department is to scale up processes within fermentation and recovery of proteins for toxicological and clinical studies of the Novo Nordisk portfolio. The department consists currently of 5 teams with several pilot facilities for fermentation, recovery as well as a team with an equipment support function.  Our mission is to develop efficient and robust API-processes for clinical trials to support our portfolio of drug candidates in Novo Nordisk. We focus on innovation, quality, and efficiency to improve the life of patients.

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 ex-perimentation, 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 
If you would like to know more about the position, please contact Manager Karen Imbæk Starlit at +45 3448 8456. 

Deadline 
15 December 2024 

The interviews will be held in January.

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, back-grounds 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. 
 

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.