Pilot Scientist with Production responsibility at CMO´s

Are you passionate about pilot production, protein purification, and drying of drug substances? Do you want to be the link between research and production and be responsible for productions at our CMO's? Do you thrive in fast-paced environment, where two days are not alike? 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!
We are looking for a highly motivated and experienced Pilot scientist for our department, with the primary focus on being production responsible for productions at our CMO's.
The department consists currently of 5 teams with several pilot facilities for purification, chemical modification, freeze drying and spray drying, 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.
The position
As a Pilot Scientist, 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.
You will be responsible for:

• 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

Since we are following GMP guidelines, we expect you to have a systematic approach to solving problems and performing your tasks, particularly in what concerns managing deviations
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, Cand. Scient., Cand. Pharm., or other related areas of expertise

• Several years of experience in protein purification or drying, either in a pilot or production environment

• 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

• Solid understanding of purification process operations, in the areas of chromatography, TFF filtrations, freeze drying, and/or spray drying.

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.
About the department
The Purification Pilot Plants departments primary responsibility is to scale-up processes with the production responsible role within purification, modification and drying of proteins for toxicological and clinical studies of the Novo Nordisk portfolio.
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
If you would like to know more about the position, please contact Associate Manager Ann-Louise Gottlieb +45 3079 4778.
Deadline
29 September 2024
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.